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
124369–124392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1990
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
K901156 · GNP
Granbio, Inc.
Microbiology · 183d
Cleared Sep 12, 1990
TRAUMA SLEEVE
K901509 · KME
Haz-Med, Inc.
General Hospital · 166d
Cleared Sep 12, 1990
(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM
K901840 · LJN
Granbio, Inc.
Microbiology · 141d
Cleared Sep 12, 1990
PROFESSIONAL MONITOR
K901907 · KPN
Travis Industries, Inc.
Gastroenterology & Urology · 138d
Cleared Sep 12, 1990
IV SET
K901949 · FPA
Jfv, Inc.
General Hospital · 135d
Cleared Sep 12, 1990
ALERT BED ALARM SYSTEM
K901969 · KMI
Alertronics, Inc.
General Hospital · 134d
Cleared Sep 12, 1990
ANOLIFT - PORTABLE & ANOLIFT - GANTRY
K902141 · FSA
Anodyne Corp.
General Hospital · 120d
Cleared Sep 12, 1990
RASTRONICS CCI 10/3 HEARING AID ANALYSIS
K902252 · ETW
Rastronics USA, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 12, 1990
ZYMALAR IMPLANT
K902284 · LZK
Applied Biomaterial Technologies
General & Plastic Surgery · 113d
Cleared Sep 12, 1990
THE MAGNUM CHIN IMPLANT
K902285 · FWP
Applied Biomaterial Technologies
General & Plastic Surgery · 113d
Cleared Sep 12, 1990
HAELAN 340 MUSCLE STIMULATOR
K902371 · IPF
Paranamics, Inc.
Physical Medicine · 106d
Cleared Sep 12, 1990
SPLIT-SECOND INTRODUCER
K902527 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 99d
Cleared Sep 12, 1990
MIC ANAL INCONTINENCE TUBE
K902684 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 85d
Cleared Sep 12, 1990
DEGUFILL (TM) WHIT-SEALANT
K902742 · EBC
Degussa AG
Dental · 82d
Cleared Sep 12, 1990
FIBER OPTIC LIGHT SOURCE
K902784 · EQH
Trek Medical Products, Inc.
Ear, Nose, Throat · 78d
Cleared Sep 12, 1990
CLEM TM
K902788 · FIB
Arbo Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 12, 1990
TISSUE/POLYP TRAP SYSTEM
K902883 · BYZ
Triton Technology, Inc.
General Hospital · 72d
Cleared Sep 12, 1990
WITTICH NITINOL STONE BASKET
K902944 · LQR
Cook, Inc.
Gastroenterology & Urology · 69d
Cleared Sep 12, 1990
COPE NITINOL STONE BASKET
K902945 · LQR
Cook, Inc.
Gastroenterology & Urology · 69d
Cleared Sep 12, 1990
BI-O.K. STEAM TEST-PAK
K903024 · FRC
Propper Mfg. Co., Inc.
General Hospital · 64d
Cleared Sep 12, 1990
LATEX FINGER COTS
K903073 · LZB
Dongkuk Trading Co., Ltd.
General Hospital · 62d
Cleared Sep 12, 1990
ALANINE AMINOTRANSFERASE TEST
K903198 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 55d
Cleared Sep 12, 1990
ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST
K903201 · MDC
Gen-Probe, Inc.
Microbiology · 54d
Cleared Sep 12, 1990
PATIENT EXAMINATION GLOVES
K903289 · LYY
Pacificlink Export Industries Private...
General Hospital · 51d