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
149617–149640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1985
PTCA BALLOON CATHETERS & ACCESSORIES
K843944 · LOX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 128d
Cleared Feb 14, 1985
BILIARY STENT PROSTHESIS
K844384 · FGE
Mentor Corp.
Gastroenterology & Urology · 93d
Cleared Feb 14, 1985
DTL ELECTRODE
K844409 · HLZ
Sauquoit Industries, Inc.
Ophthalmic · 92d
Cleared Feb 14, 1985
PHARMACIA B2-MICRO EIA
K844469 · JZG
Pharmacia, Inc.
Microbiology · 87d
Cleared Feb 14, 1985
SIEGEN VISUAL STIMULATOR
K844616 · GWE
Siegen Corp.
Neurology · 79d
Cleared Feb 14, 1985
FRESENIUS HAEMODIALYSIS
K844641 · FKQ
Seratronics, Inc.
Gastroenterology & Urology · 78d
Cleared Feb 14, 1985
PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD
K844857 · DTD
Pacesetter Systems
Cardiovascular · 62d
Cleared Feb 14, 1985
SPACELABS MODEL 90201 HOLTER RECORDER
K844940 · DSH
Spacelabs, Inc.
Cardiovascular · 56d
Cleared Feb 14, 1985
AVA-MIST PORTABLE AIR COMPRESSOR
K844956 · BTI
Avatron, Inc.
Anesthesiology · 55d
Cleared Feb 14, 1985
SPIROMETRICS 2453 & SMI III
K850045 · BTY
Spirometrics, Inc.
Anesthesiology · 38d
Cleared Feb 14, 1985
ESOPHOGEAL PH CATHETER
K850074 · FFT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 36d
Cleared Feb 14, 1985
ENTRON ENTERAL FEEDING BAG
K850134 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 31d
Cleared Feb 14, 1985
ADULT DISPOS. INCONTINENT PANTS
K850153 · EYQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 30d
Cleared Feb 14, 1985
DIGNITY PANT & ABSORBENT PADS
K850154 · EYQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 30d
Cleared Feb 14, 1985
HEART AID MODEL 97
K850170 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 29d
Cleared Feb 14, 1985
PERITONEAL DIALYSIS COIL CATHETER
K850247 · FXX
Sil-Med Corp.
General Hospital · 23d
Cleared Feb 14, 1985
COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK
K850309 · JAY
Ackrad Laboratories
Anesthesiology · 20d
Cleared Feb 14, 1985
DISPOSABLE LARYNGOSCOPE
K850437 · LLW
Vital Signs, Inc.
Obstetrics & Gynecology · 9d
Cleared Feb 13, 1985
COPAL DIGITAL SPHYGMOMANOMETER UA-510
K842388 · DXN
Takeda Medical, Inc.
Cardiovascular · 240d
Cleared Feb 13, 1985
PULSED DOPPLER OPTION, CONTINU-WAVE
K842407 · IYN
General Electric Co.
Radiology · 239d
Cleared Feb 13, 1985
AGEE EXTERNAL FIXATOR
K842493 · JEC
The Hand Biomechanics Research...
Orthopedic · 232d
Cleared Feb 13, 1985
SACRAL BAR
K843445 · KWP
Stuart
Orthopedic · 161d
Cleared Feb 13, 1985
VINGMED DS100 DOPPLER FLOWMETER
K843933 · JAF
Vingmed, Inc.
Radiology · 131d
Cleared Feb 13, 1985
AUTO DII MULTI FREQUENCY
K844293 · IYN
Technicare Corp.
Radiology · 100d