FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
124705–124728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1990
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K903316 · HGL
Ge Medical Systems Information...
Obstetrics & Gynecology · 28d
Cleared Aug 22, 1990
MAGNESIUM
K903341 · JGJ
Catachem, Inc.
Chemistry · 28d
Cleared Aug 22, 1990
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
K903359 · CGI
Immunotech Corp.
Chemistry · 28d
Cleared Aug 22, 1990
GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L
K903402 · GXY
Medi-Source, Inc.
Neurology · 22d
Cleared Aug 22, 1990
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · JSO
Bd Becton Dickinson Vacutainer...
Microbiology · 22d
Cleared Aug 21, 1990
CADD-PCA AMBULATORY INFUSION PUMPS
K896075 · FRN
Pharmacia Deltec, Inc.
General Hospital · 306d
Cleared Aug 21, 1990
AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM
K896356 · IYO
Esaote Biomedica Spa
Radiology · 288d
Cleared Aug 21, 1990
ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500
K896644 · ITX
Shimadzu Corp.
Radiology · 270d
Cleared Aug 21, 1990
ADDITIONAL TRANSDUCERS FOR USE W/SDL 300
K897073 · ITX
Shimadzu Corp.
Radiology · 242d
Cleared Aug 21, 1990
INFUSION PUMP
K901065 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 167d
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