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
159841–159864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1982
VAST VENTREX ALLERGY SYSTEMS TESTS
K821451 · DHB
Ventrex Laboratories, Inc.
Immunology · 40d
Cleared Jun 23, 1982
BARD ENDO LINK INTRACONDYLAR ROTATING
K821476 · KRO
C.R. Bard, Inc.
Orthopedic · 36d
Cleared Jun 23, 1982
STERILE CATH CARE KIT
K821500 · KDD
Pro-Pak
General & Plastic Surgery · 35d
Cleared Jun 23, 1982
THERMAL WELL TEMPERATURE SENSOR
K821504 · FLL
Mon-A-Therm, Inc.
General Hospital · 34d
Cleared Jun 23, 1982
DESERET UNIVERSAL LUER LOCK
K821525 · KGZ
Warner-Lambert Co.
General & Plastic Surgery · 33d
Cleared Jun 23, 1982
SHUR-STRIP APPLICATOR
K821763 · FPX
Shur Medical Corp.
General & Plastic Surgery · 8d
Cleared Jun 23, 1982
PEDICRAFT BED, MODEL B2944
K821773 · FMS
Pedicraft, Inc.
General Hospital · 7d
Cleared Jun 22, 1982
ACCURETTE
K820641 · HFF
Axcan Scientific Corp.
Obstetrics & Gynecology · 106d
Cleared Jun 22, 1982
C-101-P
K820939 · DXY
Coratomic, Inc.
Cardiovascular · 77d
Cleared Jun 22, 1982
INVERCHAIR
K821002 · ITH
Inverchair Marketing, Inc.
Physical Medicine · 75d
Cleared Jun 22, 1982
VARIOUS STERILE BIOPSY ASPIRATION NEED
K821017 · GAA
Medsurg Industries, Inc.
General & Plastic Surgery · 71d
Cleared Jun 22, 1982
FLUORO-CEP
K821060
Zeus Scientific, Inc.
Chemistry · 68d
Cleared Jun 22, 1982
GAMMADAB[125]EGE RADIOIMMUNOASSAY IT
K821092 · DGC
Clinical Assays, Inc.
Chemistry · 64d
Cleared Jun 22, 1982
DC PACK TM
K821134 · HFC
Seamless Hospital Products Co.
Obstetrics & Gynecology · 63d
Cleared Jun 22, 1982
CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK
K821229 · JTN
General Diagnostics
Microbiology · 56d
Cleared Jun 22, 1982
HOFFMAN UNIVERSAL FOOT SUPPORT
K821252 · KQZ
Howmedica Corp.
Orthopedic · 53d
Cleared Jun 22, 1982
CEFOPERAZONE 75MCG SENSIT- DISCS
K821262 · JTN
Difco Laboratories, Inc.
Immunology · 50d
Cleared Jun 22, 1982
CEFOPERAZONE 75MCG SENSI-DISC
K821264 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 50d
Cleared Jun 22, 1982
BN-74 COATED BARDEX ALL SILICONE CATH
K821272 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 22, 1982
DISPOSABLE IRRIGA/ASPIR. SYSTEM
K821496 · KDH
Innovative Surgical Products, Inc.
Gastroenterology & Urology · 34d
Cleared Jun 22, 1982
MARTIN-LEWIS/PRONG AGAR
K821551 · JTY
Gibco Laboratories Life Technologies,...
Microbiology · 28d
Cleared Jun 22, 1982
VENOSET DUAL-RATE PIGGYBACK W/IVEX &
K821578 · FPA
Abbott Laboratories
General Hospital · 25d
Cleared Jun 22, 1982
SANDHILL DMS
K821588 · KLA
Sandhill
Gastroenterology & Urology · 21d
Cleared Jun 22, 1982
STEAM STERILIZATION EQUIPMENT
K821591 · FLE
Getinge International, Inc.
General Hospital · 21d