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
164689–164712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1981
VECTOR-100 X-RAY GENERATOR
K802996 · IZO
Philips Medical Systems (Cleveland),...
Radiology · 45d
Cleared Jan 09, 1981
FLAME PHOTOMETRY REAGENTS
K803051 · JIX
Laboratory Products, Inc.
Pathology · 38d
Cleared Jan 09, 1981
TRIGLYCERIDES (UV)-2 REAGENTS
K803091 · CDT
Reagents Applications, Inc.
Chemistry · 32d
Cleared Jan 09, 1981
TRI-LEVEL RADIOASSAY CONTROL SERA
K803098 · JJY
American Diagnostic Corp.
Chemistry · 32d
Cleared Jan 09, 1981
HELENA HBA2 QUIK COLUMN METHOD
K803108 · JPD
Helena Laboratories
Hematology · 30d
Cleared Jan 09, 1981
PARALLEL CHEMICAL ANALYZER
K803135 · JJE
American Monitor Corp.
Chemistry · 28d
Cleared Jan 09, 1981
CONPHAR CAST HEELS
K803141 · LGF
Conphar, Inc.
Orthopedic · 28d
Cleared Jan 09, 1981
DOUBLE BALL JOINT
K803166 · JEC
Howmedica Corp.
Orthopedic · 25d
Cleared Jan 09, 1981
CARDIO ZYME PLUS CK-MB #65045
K803168 · JHW
Harleco
Chemistry · 25d
Cleared Jan 09, 1981
CARDIOZYME PLUS CK-TOTAL #65046
K803169 · JHS
Harleco
Chemistry · 25d
Cleared Jan 09, 1981
INTEROOM(POWERED OPHTHALMIC TABLE)
K803176 · HRS
Jocevest Interoom, Inc.
Orthopedic · 25d
Cleared Jan 09, 1981
1-125 LABELED TRIIODOTHYRONINE(T3)
K803180 · CDP
Pcl-Ria, Inc.
Chemistry · 24d
Cleared Jan 09, 1981
ARGYLE UNIVERSAL POOLE SUCTION TUBE
K803187 · JOL
Sherwood Medical Co.
General Hospital · 24d
Cleared Jan 09, 1981
ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED
K803190 · FRN
Ethox Corp.
General Hospital · 24d
Cleared Jan 09, 1981
CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
K803216 · CIT
Union Carbide Corp.
Chemistry · 22d
Cleared Jan 09, 1981
AMES SERA-PAK ALBUMIN REAGENT KIT
K803237 · CIX
Miles Laboratories, Inc.
Toxicology · 17d
Cleared Jan 09, 1981
SOFTGOOD PRODUCTS AND SPLINTS
K803239 · IPX
Danek Medical, Inc.
Physical Medicine · 17d
Cleared Jan 09, 1981
CORNING 760 FLUOROMETER/DENSITOMETER
K803240 · JQT
Transidyne General Corp.
Chemistry · 17d
Cleared Jan 09, 1981
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.
K803254 · CHH
Beckman Instruments, Inc.
Chemistry · 17d
Cleared Jan 09, 1981
CLOSED SYSTEM URETHRAL CATHETERIZ. SET
K803259 · KOD
Medical Devices, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 09, 1981
OSTEO OSCILAIR
K803284 · HSZ
Richard'S Medical Equip., Inc.
Orthopedic · 10d
Cleared Jan 08, 1981
DELTA-LITE CASTING TAPE & SPLINTS
K802522 · FYH
Johnson & Johnson Professionals, Inc.
General Hospital · 85d
Cleared Jan 08, 1981
ECA GEL PROUDUCT REFORMULATION
K802647 · GYB
Vanaray Laboratories, Inc.
Neurology · 80d
Cleared Jan 08, 1981
RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS.
K802674 · CAC
Haemonetics Corp.
Anesthesiology · 73d