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
161833–161856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1981
POLI-MAK II
K813102 · JJE
Pm America, Inc.
Chemistry · 21d
Cleared Nov 24, 1981
PORT-OP
K813106 · EIA
Portec, Inc.
Dental · 21d
Cleared Nov 24, 1981
S/P VORTEX MIXER
K813148 · JRQ
American Dade
Chemistry · 18d
Cleared Nov 24, 1981
S/P VORTEX MIXER JR.
K813149 · JRQ
American Dade
Chemistry · 18d
Cleared Nov 24, 1981
ORTHO UNASSAYED CONTROL SERUM LEVEL II
K813167 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Nov 24, 1981
SALICYLATE STAT-PAK
K813185 · DKJ
Clin Tech Diagnostics Corp.
Toxicology · 8d
Cleared Nov 23, 1981
MODEL P-8 PROFESSIONAL
K811114
Bloomex International, Inc.
Physical Medicine · 214d
Cleared Nov 20, 1981
HYDROXYLAPATITE
K811101 · LYC
Carbomedics, Inc.
Dental · 213d
Cleared Nov 20, 1981
IMAGER 2000 REAL TIME SYSTEM
K811842 · IYO
Siemens Gammasonics, Inc.
Radiology · 142d
Cleared Nov 20, 1981
X-RAY DETECTABLE BAND
K812017 · GDY
Isramed, Inc.
Radiology · 126d
Cleared Nov 20, 1981
X-RAY DETECTABLE THREAD
K812018 · GDY
Isramed, Inc.
Radiology · 126d
Cleared Nov 20, 1981
PORTABLE TOOTHBRUSH KIT (NO SAMPLE)
K812361 · EFW
Jdm Commodities
Dental · 92d
Cleared Nov 20, 1981
DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST
K812362 · EFW
Jdm Commodities
Dental · 92d
Cleared Nov 20, 1981
DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED
K812363 · EFW
Jdm Commodities
Dental · 92d
Cleared Nov 20, 1981
PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE
K812364 · EFW
Jdm Commodities
Dental · 92d
Cleared Nov 20, 1981
ARTHRO-PREP REST W/STAND
K812395 · BWN
Northwest Surgical Concepts, Inc.
General & Plastic Surgery · 92d
Cleared Nov 20, 1981
ARTHRO-PREP REST
K812396 · BWN
Northwest Surgical Concepts, Inc.
General & Plastic Surgery · 92d
Cleared Nov 20, 1981
TANARAMA
K812603 · GGG
Marketing Consultants of America
Radiology · 66d
Cleared Nov 20, 1981
ETHICON* SURGICAL SUTURES W/COMPRESS BOL
K812819 · KGS
Ethicon, Inc.
General & Plastic Surgery · 44d
Cleared Nov 20, 1981
SURGICAL LOOPS
K812875 · GAD
M-W Laboratories, Inc.
General & Plastic Surgery · 37d
Cleared Nov 20, 1981
SURGICAL PAWS
K812876 · GDZ
M-W Laboratories, Inc.
General & Plastic Surgery · 37d
Cleared Nov 20, 1981
BOUNDARY SURGICAL DRAPE
K812962 · KKX
The Buckeye Cellulose Corp.
General Hospital · 29d
Cleared Nov 20, 1981
STERILE IRRIGATING SYRINGES, KITS,TRAY
K813027 · KYZ
Welcon, Inc.
General Hospital · 23d
Cleared Nov 20, 1981
PERIOGRAF
K813070 · LYC
Sterling Drug, Inc.
Dental · 18d