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
163993–164016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1981
LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM
K810154 · DPS
Physio-Control Corp.
Cardiovascular · 64d
Cleared Mar 26, 1981
HELENA HEMOGLOBIN F CONTROLS
K810475 · KQI
Helena Laboratories
Hematology · 31d
Cleared Mar 26, 1981
INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL
K810520 · KRO
Zimmer, Inc.
Orthopedic · 28d
Cleared Mar 26, 1981
ADHESIVE I.V. CATHETER DRESSING
K810579 · KMK
Johnson & Johnson Professionals, Inc.
General Hospital · 23d
Cleared Mar 26, 1981
BAND-AID KITCHEN ASSORTMENT
K810623 · KGX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 17d
Cleared Mar 26, 1981
WONDER WARMER
K810633 · IMD
Montvale Products, Inc.
Physical Medicine · 16d
Cleared Mar 26, 1981
INVALID CUSHION
K810649 · KIC
First Industries, Inc.
Physical Medicine · 16d
Cleared Mar 26, 1981
CRUTCH TIPS & GRIPS
K810650 · INP
First Industries, Inc.
Physical Medicine · 16d
Cleared Mar 26, 1981
CONVAID CRUISER CP4M
K810676 · LBE
Convaid Products, Inc.
Physical Medicine · 14d
Cleared Mar 26, 1981
MEDI-LANCE
K810681 · FMK
Medicore, Inc.
Microbiology · 13d
Cleared Mar 26, 1981
SUTURE REMOVAL KIT
K810685 · GEN
Medical Action Industries, Inc.
General & Plastic Surgery · 13d
Cleared Mar 26, 1981
CURITY PERINEAL WARM PACK
K810692 · IMD
The Kendal Co.
Physical Medicine · 13d
Cleared Mar 26, 1981
CURITY PERINEAL COLD PACK
K810693 · IMD
The Kendal Co.
Physical Medicine · 13d
Cleared Mar 24, 1981
INSTA-BOND
K810517 · DYH
Lee Pharmaceuticals
Dental · 27d
Cleared Mar 24, 1981
CAST HIPPED VITALLIUM
K810518
Howmedica Corp.
Orthopedic · 27d
Cleared Mar 24, 1981
PERI-PATCH GLUE MOLD
K810530 · KGZ
Quinton, Inc.
General & Plastic Surgery · 26d
Cleared Mar 24, 1981
PERI-PATCH PERITONEAL CATHETER EXTENSION
K810531 · KGZ
Quinton, Inc.
General & Plastic Surgery · 26d
Cleared Mar 24, 1981
PCA PERIOCARE PERIODONTAL DRESSING
K810545 · EMA
Pulpdent Corp. of America
Dental · 25d
Cleared Mar 24, 1981
SARA
K810585 · CBS
Allied Healthcare Products, Inc.
Anesthesiology · 20d
Cleared Mar 24, 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587 · JIS
Syva Co.
Chemistry · 20d
Cleared Mar 24, 1981
CRYSTALLOY-P
K810594 · EJH
Shofu Dental Corp.
Dental · 18d
Cleared Mar 24, 1981
SILUX RESTORATIVE MATERIAL & ENAMEL BOND
K810595 · EBF
3M Company
Dental · 18d
Cleared Mar 24, 1981
CAPD EXCHANGE SET
K810600 · KDJ
American Mcgaw
Gastroenterology & Urology · 18d
Cleared Mar 24, 1981
FULCAST/SUMMIT CASTING ALLOY
K810611 · EJH
C.Vaupel Dental, Inc.
Dental · 18d