FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
125305–125328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1990
LUMISCOPE ALTERNATING PRESSURE PAD & PUMP
K901096 · FNM
Lumiscope Co., Inc.
General Hospital · 167d
Cleared Aug 21, 1990
GLOVE LEAK DETECTOR
K901237 · LDQ
Utah Medical Products, Inc.
General & Plastic Surgery · 159d
Cleared Aug 21, 1990
LEVEEN PERITINEO-VENOUS SHUNT
K901360 · KPM
Bd Becton Dickinson Vacutainer...
Gastroenterology & Urology · 151d
Cleared Aug 21, 1990
LASER FORCEPS HANDPIECE
K901365 · GEX
Lca, Inc.
General & Plastic Surgery · 151d
Cleared Aug 21, 1990
SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF
K901422 · LLZ
Image Systems, Inc.
Radiology · 148d
Cleared Aug 21, 1990
DANEK SACRAL HOOK
K901590 · KWP
Danek Medical, Inc.
Orthopedic · 138d
Cleared Aug 21, 1990
WHENEVER(R) UNSCENTED SUPER MAXI PAD
K901690 · HHD
Marcal Paper Mills, Inc.
Obstetrics & Gynecology · 133d
Cleared Aug 21, 1990
MCGRATH ORTHOPAEDIC BONE SCREWS
K901814 · HWC
Mcgrath Surgical , Ltd.
Orthopedic · 120d
Cleared Aug 21, 1990
KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD
K902000 · FZS
Kevtek Medical Products, Inc.
General & Plastic Surgery · 111d
Cleared Aug 21, 1990
SABA CONFORT MENSTRUAL PAD
K902160 · HHD
Valle & Assoc.
Obstetrics & Gynecology · 97d
Cleared Aug 21, 1990
O. B. PACK III
K902273 · HHD
Customed, Inc.
Obstetrics & Gynecology · 92d
Cleared Aug 21, 1990
PATIENT EXAMINATION GLOVES
K903656 · LYY
United Rubber Corp. (Sabah) Sdn. Bhd.
General Hospital · 12d
Cleared Aug 20, 1990
GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.
K902311 · LNJ
Applied Imaging Corp.
Pathology · 89d
Cleared Aug 17, 1990
COBAS READY CALCIUM REAGENT
K896224 · CIC
Roche Diagnostic Systems, Inc.
Chemistry · 291d
Cleared Aug 17, 1990
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
K896497 · DSP
Datascope Corp.
Cardiovascular · 276d
Cleared Aug 17, 1990
ANESTHESIA BREATHING CIRCUITS
K900428 · CAI
Med-Tek Corp.
Anesthesiology · 199d
Cleared Aug 17, 1990
PERNECZKY ANEURYSM CLIP
K901312 · HCH
Von Zeppelin GmbH
Neurology · 150d
Cleared Aug 17, 1990
RTS TECHNOLOGY IRIDIUM 192 SOURCES
K901589 · JAQ
Rts Technology, Inc.
Radiology · 143d
Cleared Aug 17, 1990
PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
K901920 · BTO
Primecare, Inc.
Anesthesiology · 109d
Cleared Aug 17, 1990
MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL
K901952 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 108d
Cleared Aug 17, 1990
WINGED INFUSION SET
K902166 · FPA
Therex Corp.
General Hospital · 94d
Cleared Aug 17, 1990
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · CAP
Respironics, Inc.
Anesthesiology · 88d
Cleared Aug 17, 1990
BUSSE BAC/SHIELD
K902297 · BSY
Busse Hospital Disposables, Inc.
Anesthesiology · 86d
Cleared Aug 17, 1990
SHAW II HEMOSTATIC SURGERY SYSTEM
K902307 · GEI
Hemostatic Surgery Corp.
General & Plastic Surgery · 87d