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
152137–152160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1984
RIM STREP KIT
K842451 · JSE
Austin Biological Laboratories
Microbiology · 10d
Cleared Jul 02, 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K842457 · DHB
Pharmacia, Inc.
Immunology · 10d
Cleared Jun 28, 1984
ARGYLE ENTERNAL FEEDING BAG W/ADMIN
K840877 · HFS
Sherwood Medical Co.
General Hospital · 122d
Cleared Jun 28, 1984
MEDILOG PH1
K840934 · EXW
Oxford Medilog, Inc.
Gastroenterology & Urology · 115d
Cleared Jun 28, 1984
INTRAVASCULAR CATHETER SECUREMENT DEV
K841487 · KMK
Tapemark Co.
General Hospital · 79d
Cleared Jun 28, 1984
VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD
K841679 · LJT
Norfolk Medical Products, Inc.
General Hospital · 66d
Cleared Jun 28, 1984
SKYNDEX ELECTRONIC BODY FAT CALCULA
K841687 · KTZ
Caldwell, Justiss & Co., Inc.
Chemistry · 66d
Cleared Jun 28, 1984
THINWALL PUNCTURE NEEDLE
K841704 · FMI
Meadox Surgimed, Inc.
General Hospital · 66d
Cleared Jun 28, 1984
ENDOPORT EROCAR
K841716 · FBQ
Endotherapeutics
General & Plastic Surgery · 64d
Cleared Jun 28, 1984
CRITIKON I.V. FILTER
K842075 · FPB
Critikon Company, LLC
General Hospital · 36d
Cleared Jun 28, 1984
PIRD-Y
K842262 · ISB
Pirdy, Inc.
Physical Medicine · 21d
Cleared Jun 28, 1984
DIALYSATE ADDITIVES
K842294 · FKQ
Dialysis Products, Inc.
Gastroenterology & Urology · 17d
Cleared Jun 28, 1984
PRESSURE RELIEF SEAT CUSHION
K842380 · KIC
American Pharmaseal Div. Ahsc
Physical Medicine · 10d
Cleared Jun 28, 1984
PARA THERM BATH
K842423 · IMC
Grimm Scientific Industries, Inc.
Physical Medicine · 8d
Cleared Jun 27, 1984
FORMA-FAS-TEST
K833128 · LIF
Chemical Detection & Experimentation
Pathology · 288d
Cleared Jun 27, 1984
VENTRAL WALL DEFECT REDUCT SILO
K840172 · FTL
American Heyer Schulte
General & Plastic Surgery · 162d
Cleared Jun 27, 1984
RESTODENT DENTIN BONDING AGENT
K840726 · KLE
Lee Pharmaceuticals
Dental · 127d
Cleared Jun 27, 1984
DEMLAR SYS I COMPUTER BASED AUDIOMETER
K841167 · EWO
Demlar Medical, Inc.
Ear, Nose, Throat · 100d
Cleared Jun 27, 1984
GLATTELAST COMPRESSION PANTY HOSE
K841252 · DWL
Baurs Krey Assoc., Inc.
General Hospital · 93d
Cleared Jun 27, 1984
STELDENT - DENTAL ALLOY
K841290 · EJH
Eriez
Dental · 90d
Cleared Jun 27, 1984
FUZZY TRAY
K841323 · EHY
Buffalo Dental Mfg. Co., Inc.
Dental · 86d
Cleared Jun 27, 1984
OTICON E28A
K841436 · ESD
Oticon Corp.
Ear, Nose, Throat · 82d
Cleared Jun 27, 1984
POLYSULFIDE CUSTOM TRAY MATERIAL
K841490 · ELW
Buffalo Dental Mfg. Co., Inc.
Dental · 78d
Cleared Jun 27, 1984
AUDIOMETER MA728
K841567 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 71d