Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
148417–148440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1985
TIPSEP DIGOXIN RIA
K852291 · DNL
Nuclear Diagnostics, Inc.
Toxicology · 27d
Cleared Jun 25, 1985
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
K852317 · KLQ
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jun 25, 1985
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
K852318 · LFT
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jun 25, 1985
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS
K852319 · LAN
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jun 24, 1985
OMS SILICONE OIL INJECTOR
K844895 · LWL
Optical Micro Systems, Inc.
Ophthalmic · 189d
Cleared Jun 24, 1985
COROMETRICS 500 INFANT MONITOR
K850504 · BZQ
Ge Medical Systems Information...
Anesthesiology · 136d
Cleared Jun 24, 1985
LASERFLO BLOOD PERFUSION MONITOR 403
K851057 · DPW
Tsi, Inc.
Cardiovascular · 102d
Cleared Jun 24, 1985
MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR
K851152 · DWS
Cryomedics, Inc.
Cardiovascular · 95d
Cleared Jun 24, 1985
ELECTRA 800 AUTOMATIC COAGULATION TIMER
K851169 · KQG
Medical Laboratory Automation...
Pathology · 94d
Cleared Jun 24, 1985
PAPILLOTOME
K851652 · KNS
Microvasive
Gastroenterology & Urology · 63d
Cleared Jun 24, 1985
SAFESEAL REUSABLE URINAL SYSTEM
K851682 · EXJ
Dbt Medical , Ltd.
Gastroenterology & Urology · 62d
Cleared Jun 24, 1985
STOMAHESIVE SKIN BARRIER STERILE
K851840 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 59d
Cleared Jun 24, 1985
MEDICAL TOILET SEAT
K852049 · ILS
Pedro Aleman
Physical Medicine · 47d
Cleared Jun 24, 1985
DEVO/MC29 OXYGEN CONCENTRATOR MC29D
K852209 · CAW
The Devilbiss Co.
Anesthesiology · 34d
Cleared Jun 24, 1985
TENS-AID STERILE ELECTRODES FOR POST-OP TENS
K852298 · GXY
Staodynamics, Inc.
Neurology · 26d
Cleared Jun 24, 1985
ST-460 SPIRO ANALYZER SPIROMETER
K852308 · BZG
Futuremed Div. of Future Impex Corp.
Anesthesiology · 26d
Cleared Jun 24, 1985
ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR
K852515 · BZQ
Alternative Design Systems, Inc.
Anesthesiology · 11d
Cleared Jun 21, 1985
FUKUDA DENSHI EH-11
K834059 · DXG
Fukuda Denshi USA, Inc.
Cardiovascular · 574d
Cleared Jun 21, 1985
ELISA FOR HERPES SIMPLEX VIRUS
K843077 · LGC
Scientific Research
Microbiology · 319d
Cleared Jun 21, 1985
TROCHANTER CABLE GRIP SYSTEM
K844068 · KTT
Howmedica Corp.
Orthopedic · 246d
Cleared Jun 21, 1985
CARDIOVASCULAR CUSTOM SURGICAL KIT
K844593 · DYB
Xanmed Corp.
Cardiovascular · 207d
Cleared Jun 21, 1985
PERCUTANEOUS ANGIOGRAPHIC NEEDLES
K845037 · DYB
Mallinckrodt Critical Care
Cardiovascular · 176d
Cleared Jun 21, 1985
ENDO-TUBE
K850664 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 121d
Cleared Jun 21, 1985
GRAVITY TRACTION TABLE
K851007 · INQ
William F. Trinkaus
Physical Medicine · 101d