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
170785–170808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1978
FTA-ABS TEST SYSTEM
K781403 · GMS
Zeus Scientific, Inc.
Microbiology · 6d
Cleared Aug 21, 1978
RID SYSTEM-(ACP) TEST
K781408 · DEM
Icl Scientific
Immunology · 7d
Cleared Aug 18, 1978
IMPERVIOUS STOCKINET
K781046 · KKX
Spartan Healthcare Products Co.
General Hospital · 58d
Cleared Aug 18, 1978
DRAPE, SURGICAL-SPARTAN LIMB SHEET
K781047 · KKX
Spartan Healthcare Products Co.
General Hospital · 58d
Cleared Aug 18, 1978
OSTOMY APPLIANCE BELT
K781088 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 18, 1978
BANDAGE, COMPRESSION, FISTULAID
K781110 · DJC
Medical Device Laboratories
Toxicology · 46d
Cleared Aug 18, 1978
RESTORATIVE SYSTEM PROFILE
K781293 · EBF
The S. S. White Co.
Dental · 22d
Cleared Aug 17, 1978
MILLARD MOUTH GAG
K780992 · KBN
Nestor Engineering Associates, Inc.
Ear, Nose, Throat · 64d
Cleared Aug 17, 1978
K-Z CONCENTRATE
K781011 · EXB
K-Zyme Labs, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 17, 1978
CATHETER, THERMAL DILUTION FIBEROPTIC
K781134 · DQE
Oximetrix, Inc.
Cardiovascular · 42d
Cleared Aug 17, 1978
ENZYMATIC TRIGLYCERIDES REAGENT KIT
K781240 · CDT
J.T. Baker Chemical Co.
Chemistry · 28d
Cleared Aug 17, 1978
STERILE WET DRESSING PACK
K781322 · EFQ
W.G. Whitney Corp.
General & Plastic Surgery · 17d
Cleared Aug 17, 1978
A-V FISTULA NEEDLE
K781331 · DJC
Bd Becton Dickinson Vacutainer...
Toxicology · 15d
Cleared Aug 17, 1978
DISPOSABLE SYRINGE FILL TUBE
K781334 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 15d
Cleared Aug 15, 1978
NEUROSTAT, LLOYD
K781302 · GXH
Spembly Medical , Ltd.
Neurology · 18d
Cleared Aug 15, 1978
ENDOTRACHEAL TUBE
K781339 · BTR
Life-Line Products, Inc.
Anesthesiology · 12d
Cleared Aug 14, 1978
MAXICEPTOR
K780632 · ISB
Med General
Physical Medicine · 119d
Cleared Aug 14, 1978
ASPIRATION NEEDLE
K780784 · KKX
Ferris Mfg. Corp.
General Hospital · 94d
Cleared Aug 14, 1978
BARRIER PEDIATRIC/INCISE DRAPE 450
K780839 · KKX
Surgikos, Inc.
General Hospital · 83d
Cleared Aug 14, 1978
BARRIER LAPAROTOMY SHEET 450
K780840 · KKX
Surgikos, Inc.
General Hospital · 83d
Cleared Aug 14, 1978
BARRIER MEDIUM SHEET 450
K780841 · KKX
Surgikos, Inc.
General Hospital · 83d
Cleared Aug 14, 1978
BARRIER BASIC PACK FABRIC 450
K780842 · KKX
Surgikos, Inc.
General Hospital · 84d
Cleared Aug 14, 1978
BARRIER ABDOMINAL PACK FABRIC 450
K780843 · KKX
Surgikos, Inc.
General Hospital · 84d
Cleared Aug 14, 1978
BARRIER OBSTETRICAL PACK FABRIC 450
K780844 · KKX
Surgikos, Inc.
General Hospital · 84d