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Panels › Obstetrics/Gynecology › Product code MLT · Class 2

Pelvic Exam Kit

Regulation 884.4530

0510(k)s in 12 months (1 all time)
2recalls in 12 months (10 all time)
0recalls that name a 510(k)
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Top companies in MLT

Company510(k)sRecalls
MEDLINE INDUSTRIES, LP - Northfield04
Centurion Medical Products Corporation03
Medline Industries, LP02
Carapace, Inc.10
DeRoyal Industries Inc01
DateFirm and productCodeLinked 510(k)
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B
Open, Classified		 MLTNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M
Open, Classified		 MLTNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
Open, Classified		 MLTNone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
Open, Classified		 MLTNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE
Open, Classified		 MLTNone listed
Jul 3, 2023DeRoyal Industries Inc
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Open, Classified		 MLTNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
Open, Classified		 MLTNone listed
Dec 11, 2019Centurion Medical Products Corporation
Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
Terminated		 MLTNone listed
Dec 11, 2019Centurion Medical Products Corporation
Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE
Terminated		 MLTNone listed
Dec 11, 2019Centurion Medical Products Corporation
Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790
Terminated		 MLTNone listed

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