FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91993–92016 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1997
MERCURY MEDICAL REUSABLE CPR BAG
K970756 · BTM
Mercury Medical
Anesthesiology · 242d
Cleared Oct 31, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
K971375 · EOB
Wilson Greatbatch Technologies, Inc.
Ear, Nose, Throat · 200d
Cleared Oct 31, 1997
IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)
K972021 · LTJ
Diagnostic Products Corp.
Immunology · 151d
Cleared Oct 31, 1997
CURVTEK TSR SYSTEM
K972860 · HSZ
Biolectron, Inc.
Orthopedic · 88d
Cleared Oct 31, 1997
AMPLAID 171S
K972862 · EWO
Amplifon S.P.A.
Ear, Nose, Throat · 88d
Cleared Oct 31, 1997
APOLLO
K972882 · KGI
Norland Corp.
Radiology · 87d
Cleared Oct 31, 1997
DUET GLUCOSE CONTROL MONITORING SYSTEM
K973140 · CGA
Lxn Corp.
Chemistry · 71d
Cleared Oct 31, 1997
ACCUCOLOR HIGH CALIBRATOR (A3089)
K973274 · GIZ
Sigma Diagnostics, Inc.
Hematology · 59d
Cleared Oct 31, 1997
ACTIVE INTACT PTH
K973514 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 44d
Cleared Oct 31, 1997
QUICK CARD HCG ONE STEP PREGNANCY TEST
K973570 · LCX
Phamatech
Chemistry · 42d
Cleared Oct 31, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743 · CHP
Beckman Instruments, Inc.
Chemistry · 30d
Cleared Oct 31, 1997
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973966 · CDP
Beckman Instruments, Inc.
Chemistry · 14d
Cleared Oct 30, 1997
HX-20/21-1 ENDOSCOPIC LIGATOR
K964661 · MND
Olympus America, Inc.
Gastroenterology & Urology · 344d
Cleared Oct 30, 1997
CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT
K970638 · DXC
Cardiothoracic Systems, Inc.
Cardiovascular · 252d
Cleared Oct 30, 1997
SONICSYS INLAY
K972648 · EIH
Ivoclar North America, Inc.
Dental · 107d
Cleared Oct 30, 1997
INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
K972842 · LYC
Interpore Intl.
Dental · 90d
Cleared Oct 30, 1997
NARKOMED MRI ANESTHESIA SYSTEM
K972848 · BSZ
Draeger Medical, Inc.
Anesthesiology · 90d
Cleared Oct 30, 1997
ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
K972878 · FMF
Safety Syringes, Inc.
General Hospital · 87d
Cleared Oct 30, 1997
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL...
K972885 · FMT
Fisher & Paykel Electronics , Ltd.
General Hospital · 86d
Cleared Oct 30, 1997
SURGIC II IMPLANT CONTROL UNIT
K972924 · EBW
Nsk Nakanishi, Inc.
Dental · 83d
Cleared Oct 30, 1997
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K973051 · CAD
Draeger Medical, Inc.
Anesthesiology · 76d
Cleared Oct 30, 1997
SONIQUE HAIR REMOVER
K973174 · KCX
Global TV Concepts, Ltd.
General & Plastic Surgery · 66d
Cleared Oct 30, 1997
FEMINIQUE SONIC HAIR REMOVER
K973179 · KCX
Global TV Concepts, Ltd.
General & Plastic Surgery · 66d
Cleared Oct 30, 1997
ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE
K973253 · KPO
International Medical Products, Inc.
Gastroenterology & Urology · 62d