ClearanceBrief
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

CodeDeviceRecords
OJHOrthopedic Tray55
OEZCardiovascular Procedure Kit22
LROGeneral Surgery Tray20
FDELaparoscopy Kit15
OJGNeurological Tray13
MLSLabor And Delivery Kit10
NWUEndoscope Introducer Kit9
OESCardiac Catheterization Kit8
OGREar, Nose, And Throat Surgical Tray7
OEQAngiography/Angioplasty Kit6
OHDGynecological Laparoscopic Kit6
OHMCesarean Section Tray6
FTNPlastic Surgery And Accessories Kit4
OJFHysterectomy Kit4
OJKEye Tray4
OKEPort Introducer Kit4
FCHTray, Biopsy, Without Biopsy Instruments3
JSMCulture Media, Non-Propagating Transport3
OFFCentral Venous Catheter Tray3
OIPRadiology-Diagnostic Kit2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 25, 2026American 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
OJFNone listed
Sep 25, 2026American 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
OEZNone listed
Sep 25, 2026American Contract Systems Inc
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
Open, Classified
FDENone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
Open, Classified
OEZNone listed
Aug 21, 2026American Contract Systems Inc
American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
Open, Classified
OEZNone listed
Aug 20, 2026American 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
OJHNone listed
Aug 20, 2026American 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
OJGNone listed
May 6, 2026American Contract Systems Inc
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Open, Classified
LRONone listed
Oct 16, 2025American Contract Systems Inc.
Medical convenience kits IHDC30R D AND C PACK
Open, Classified
PKFNone listed
Oct 16, 2025American Contract Systems Inc.
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
Open, Classified
OKENone listed
Oct 16, 2025American 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
OJKNone listed
Oct 16, 2025American 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
OJHNone listed
Oct 16, 2025American 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
OJGNone listed
Oct 16, 2025American Contract Systems Inc.
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
Open, Classified
OIPNone listed
Oct 16, 2025American Contract Systems Inc.
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
Open, Classified
OHMNone listed
Oct 16, 2025American 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
OEQNone listed
Oct 16, 2025American 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
OHDNone listed
Oct 16, 2025American Contract Systems Inc.
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
Open, Classified
OGRNone listed
Oct 16, 2025American 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
OFFNone listed
Oct 16, 2025American 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
OEZNone listed
Oct 16, 2025American 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
OESNone listed
Oct 16, 2025American 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
NWUNone listed
Oct 16, 2025American 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
MLSNone listed
Oct 16, 2025American 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
LRONone listed
Oct 16, 2025American 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
FDENone listed
Oct 16, 2025American Contract Systems Inc.
Basic Biopsy Tray, Item Number NMBP44L
Open, Classified
FCHNone listed
Aug 28, 2025American 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
OJHNone listed
Aug 28, 2025American 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
OJFNone listed
Aug 28, 2025American 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
OHDNone listed
Aug 28, 2025American 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
MLSNone listed
Aug 28, 2025American 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
OJGNone listed
Aug 28, 2025American 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
LRONone listed
Aug 28, 2025American 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
NWUNone listed
Aug 28, 2025American 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
FDENone listed
Aug 28, 2025American 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
OEZNone listed
Jun 6, 2025American 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
OJHNone listed
Mar 21, 2025American 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
OESNone listed
Mar 21, 2025American 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
FDENone listed
Mar 21, 2025American Contract Systems, Inc.
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
Open, Classified
NWUNone listed
Mar 20, 2025American Contract Systems Inc
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Open, Classified
OJGNone listed
Mar 14, 2025American Contract Systems Inc
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
Open, Classified
OJGNone listed
Mar 14, 2025American Contract Systems Inc
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Open, Classified
LRONone listed
Mar 14, 2025American Contract Systems Inc
AV FISTULA , Model No UTAV77T
Open, Classified
OEZNone listed
Mar 14, 2025American Contract Systems Inc
NEURO IR TRAY , Model No WENI56J
Open, Classified
OJGNone listed

Newest 50 of 213.

Get alerts for these product codes