Company
American Contract Systems Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
213recalls (10 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OJH | Orthopedic Tray | 55 |
| OEZ | Cardiovascular Procedure Kit | 22 |
| LRO | General Surgery Tray | 20 |
| FDE | Laparoscopy Kit | 15 |
| OJG | Neurological Tray | 13 |
| MLS | Labor And Delivery Kit | 10 |
| NWU | Endoscope Introducer Kit | 9 |
| OES | Cardiac Catheterization Kit | 8 |
| OGR | Ear, Nose, And Throat Surgical Tray | 7 |
| OEQ | Angiography/Angioplasty Kit | 6 |
| OHD | Gynecological Laparoscopic Kit | 6 |
| OHM | Cesarean Section Tray | 6 |
| FTN | Plastic Surgery And Accessories Kit | 4 |
| OJF | Hysterectomy Kit | 4 |
| OJK | Eye Tray | 4 |
| OKE | Port Introducer Kit | 4 |
| FCH | Tray, Biopsy, Without Biopsy Instruments | 3 |
| JSM | Culture Media, Non-Propagating Transport | 3 |
| OFF | Central Venous Catheter Tray | 3 |
| OIP | Radiology-Diagnostic Kit | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | American Contract Systems Inc Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays
ABDOMINAL HYSTERECTOMY - 205989
Model No. MHAH55AM
LAVH-LAP COLON
Model No. SPLL54U
VAG HYST Open, Classified |
OJF | None listed |
| Sep 25, 2026 | American Contract Systems Inc Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays
CARDIAC HEART BUNDLE NS
Model No. LMCH99P
OPEN HEART 2 RCH 0248495
Model No. RCOH62C Open, Classified |
OEZ | None listed |
| Sep 25, 2026 | American Contract Systems Inc Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays
ROBOTIC PACK - 242561
Model No. MHRB88AO Open, Classified |
FDE | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN Open, Classified |
OEZ | None listed |
| Aug 21, 2026 | American Contract Systems Inc American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM Open, Classified |
OEZ | None listed |
| Aug 20, 2026 | American Contract Systems Inc American Contract Systems medical procedure kits and trays labeled as:
1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH;
2) SPINE PACK - 206013, Model Item Number MHSP99AF. Open, Classified |
OJH | None listed |
| Aug 20, 2026 | American Contract Systems Inc American Contract Systems medical procedure kits and trays labeled as:
1) CRANI PACK - 208400, Model Item Number UDCP57AI;
2) SPINE PACK, Model Item Number HSLM53AC;
3) CRANIAL PACK - 205992, Mode Open, Classified |
OJG | None listed |
| May 6, 2026 | American Contract Systems Inc Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor
CORONARY ANGIO PACK
Model numbers ANCA80AP
ANCA80AQ Open, Classified |
LRO | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
IHDC30R D AND C PACK Open, Classified |
PKF | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
UDPG88W PICC G-TUBE PACK-230209 Open, Classified |
OKE | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
BFCT04X CATARACT PACK - 205986
CMEY17AI EYE PACK - 213187
CMEY17AI EYE PACK - 213187
CMEY17AI EYE PACK - 213187
PERP25AQ PEI RETINAL PACK-206025
RFEY Open, Classified |
OJK | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
ANSH14AF SHOULDER PACK - 205962
EVAH76H ANTERIOR HIP PACK
FDSA15M SHOULDER ARTHROSCOPY
GRTS90G TOTAL SHPULDER PACK
HGHI26G HIP PINNING PACK
HJTO25C Open, Classified |
OJH | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
HSLM53AB SPINE PACK
MILM82A DTC LAMINECTOMY PACK (PS 209475)
RCNA47B NEURO ANGIO 0246971
SFLM54AB LAMINECTOMY PACK - 219659
UDLM94AA LAMINECTOMY PACK Open, Classified |
OJG | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
LKRA40G RADIOLOGY PACK Open, Classified |
OIP | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
FHCP08Y C SECTION PK
HICS50I C-SECTION PACK
HSCB90B C-SECTION BASIN PACK Open, Classified |
OHM | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
HSAN63N ANGIO PACK
IHAN02W ANGIOGRAPHY PACK
MHCA98AK CORONARY ANGIO PACK- 205991
RCAN45C ANGIO CUSTOM RCH
UDCO10F CVL CORONARY PACK 219224 Open, Classified |
OEQ | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
RCGY52D GYN LAPAROSCOPY SPH 0246965
UIGN82M GYN (PS 907645)
UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634) Open, Classified |
OHD | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
RCEN25B ENT SDSC 0246972
RCHN27D HEAD AND NECK RCH 0246951 Open, Classified |
OGR | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT
UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT Open, Classified |
OFF | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
ANCV78BC HEART PACK - 205947
HGCV05K CV SET UP PACK
MHPP97AR PACEMAKER PACK- 206010
UDBH37AW BASIC HEART PACK - 206044
UHPP82AH PERIPHERAL PACK - 209 Open, Classified |
OEZ | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
EVLH67F LEFT HEART CATH PACK
FDCL22R CATH LAB ANGIO
IHCC03X CATH CARDIAC PACK
TNCC02AD CARDIAC CATH TRINITY
UICC27AG CARDIAC CATH ANGIO PACK (PS 9230 Open, Classified |
OES | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item Number/Description
BUCY78E CYSTO PACK
CMCP10X CYSTO PACK - 205972
IHCY10Y CYSTO PACK
MHCY35AE CYSTO PACK- 212487
PLBY52E CYSTO PACK
UDCY31Z CYSTO PACK - 206047
UICY28L Open, Classified |
NWU | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item number/ Product description
AHLD15X LABOR DELIVERY PACK - 213387
AKDV96B VAGINAL DELIVERY
AKDV96B VAGINAL DELIVERY
EVBH28D BIRTHING ROOM PACK
UPVD01K VAGINAL DELIVERY P Open, Classified |
MLS | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
Item number/ Product description
AKGN82E GENERAL
AMCB08Y CHEST BREAST PACK
ANBP10AC BASIC PACK - 205939
ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953
CFLA39G LAPAROTOMY PA Open, Classified |
LRO | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Basic Biopsy Tray;
Item Number/Description:
AKRB26D
ROBOTIC,
AMGL09AA
GENERAL LAPAROSCOPY,
ANLC35AD
LAP CHOLE PACK - 205956,
ANLP25AJ
LAPROSCOPY PACK - 205958,
FYLA38E
LAPCHOLAPPY PACK,
IHDA88AH
DIVIN Open, Classified |
FDE | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Basic Biopsy Tray, Item Number NMBP44L Open, Classified |
FCH | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N;
2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F;
3)HIP PROTHESIS PACK, MOD Open, Classified |
OJH | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E;
2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P. Open, Classified |
OJF | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I;
2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G. Open, Classified |
OHD | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C;
2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I. Open, Classified |
MLS | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W;
2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V. Open, Classified |
OJG | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X;
2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;
Open, Classified |
LRO | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) CYSTO, Model/Item Number ASCY24A;
2) CYSTO PACK, Model/Item Number BUCY78E;
3) CYSTO PACK, Model/Item Number LMCP22T;
4) Open, Classified |
NWU | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) LAP CHOLE PACK, Model/Item Number CILC69L;
2) LAP CHOLE PACK, Model/Item Number HNLC80J;
3) LAP CHOLE PACK, Model/Item Nu Open, Classified |
FDE | None listed |
| Aug 28, 2025 | American Contract Systems Inc AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC;
2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB;
3) OFF PUMP CABG Open, Classified |
OEZ | None listed |
| Jun 6, 2025 | American Contract Systems, Inc. LOWER EXTREMITY, Model: NCEX20I;
LOWER EXTREMITY, Model: NCEX20J;
TOTAL KNEE PACK, Model: NCTK31K;
TOTAL KNEE PACK, Model: NCTK31L
All convenience kits contain Specialist Blend Cast Padding, Item: Q Open, Classified |
OJH | None listed |
| Mar 21, 2025 | American Contract Systems, Inc. Brand Name: Banner University Med Ctr.
Product Name: Cardiac Cath Lab Pack-170278
Model/Catalog Number: GSCC40G
Software Version: N/A
Product Description: Convenience Kit
Component: No Open, Classified |
OES | None listed |
| Mar 21, 2025 | American Contract Systems, Inc. Brand Name: Banner Health Systems
Product Name: Lap Pack - 170307
Model/Catalog Number: BHLP62H
Software Version: N/A
Product Description: Convenience Kit
Component: No Open, Classified |
FDE | None listed |
| Mar 21, 2025 | American Contract Systems, Inc. Brand Name: Banner Health Systems
Product Name: Cysto Pack
Model/Catalog Number: BHCY31E
Product Description: Convenience Kit
Component: No Open, Classified |
NWU | None listed |
| Mar 20, 2025 | American Contract Systems Inc CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. Open, Classified |
OJG | None listed |
| Mar 14, 2025 | American Contract Systems Inc VEIN TRAY, Model No UTVT21C
UTVT21C02
UTVT21C-03 Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc THORACIC PACK
, Model No UTTC82Y
UTTC82AA-01 Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc SPINE LUMBAR PACK
, Model No UTSL72AA
UTSL72AB Open, Classified |
OJG | None listed |
| Mar 14, 2025 | American Contract Systems Inc OPEN HEART A PACK
, Model No UTOH19AI
UTOH19AJ-01
UTOH19AJ-02 Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc MAJOR VASCULAR PACK
, Model No UTMV78X-01
UTMV78Y
UTMV78Y-01
UTMV78X-01
UTMV78Y-02 Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc GENERAL LAPAROSCOPIC PACK-LF
, Model No UTGL53S-06
UTGL53S-07
UTGL53S-08 Open, Classified |
LRO | None listed |
| Mar 14, 2025 | American Contract Systems Inc AV FISTULA
, Model No UTAV77T Open, Classified |
OEZ | None listed |
| Mar 14, 2025 | American Contract Systems Inc NEURO IR TRAY
, Model No WENI56J Open, Classified |
OJG | None listed |
Newest 50 of 213.