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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
107953–107976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 1994
TENS-IT
K933368 · GZJ
Electro Med Supply, Inc.
Neurology · 333d
Cleared Jun 07, 1994
CATH-SEAL
K935077 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 228d
Cleared Jun 07, 1994
THE REEL THING
K940156 · GBX
Bio-Medical Devices, Inc.
General & Plastic Surgery · 146d
Cleared Jun 07, 1994
EXCEL TX
K940200 · ITH
Excel Tech. , Ltd.
Physical Medicine · 145d
Cleared Jun 07, 1994
MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM)
K940572 · KMF
Merocel Corp.
General & Plastic Surgery · 119d
Cleared Jun 07, 1994
MODEL TM EP HIGH VOLTAGE GENERATOR
K942100 · IZO
Continental X-Ray Corp.
Radiology · 42d
Cleared Jun 06, 1994
OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES
K926594 · HET
Owens Industries, Inc.
Obstetrics & Gynecology · 635d
Cleared Jun 06, 1994
MARINR SERIES EP DIAGNOSTIC CATHETERS
K931794 · DRF
Medtronic Cardiorhythm
Cardiovascular · 420d
Cleared Jun 06, 1994
CD-CHEX CD4 LOW
K931825 · GGL
Streck Laboratories, Inc.
Hematology · 426d
Cleared Jun 06, 1994
MODEL T131 MEMORY TRANSMITTER
K933021 · DXH
Biometric Products, Inc.
Cardiovascular · 349d
Cleared Jun 06, 1994
UNIVERSAL INSET PATELLA
K933867 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 301d
Cleared Jun 06, 1994
PARAPOST XT SYSTEM
K934192 · ELR
Coltene/Whaledent, Inc.
Dental · 284d
Cleared Jun 06, 1994
PROVIDENT HIP SYSTEM
K935484 · LPH
Stelkast Company
Orthopedic · 203d
Cleared Jun 06, 1994
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24
K936062 · LYY
Hartalega Sdn Bhd
General Hospital · 168d
Cleared Jun 06, 1994
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929
K936063 · LYY
Hartalega Sdn Bhd
General Hospital · 168d
Cleared Jun 06, 1994
REUSABLE, HAND CONTROLLED ESP
K936075 · GEI
E & M Engineering, Inc.
General & Plastic Surgery · 168d
Cleared Jun 06, 1994
SUNGLASSES
K940659 · HQY
Leonardo, Inc.
Ophthalmic · 111d
Cleared Jun 06, 1994
VIT CUTTER MODEL 94
K940746 · HQE
Visioncare Devices, Inc.
Ophthalmic · 108d
Cleared Jun 06, 1994
DISPOSABLE PROPHY ANGLE
K941009 · EGS
Allpro, Inc.
Dental · 97d
Cleared Jun 06, 1994
XIAMEN DYNASTY OPTICAL CORP
K941119 · HQY
Xiamen Dynasty Optical Corp. , Ltd.
Ophthalmic · 91d
Cleared Jun 06, 1994
KNOT SLIDE 8383.55 AND 8383.551
K941136 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 88d
Cleared Jun 06, 1994
ANGIOREX CAS-05A
K941177 · IZI
Toshiba America Medical Systems, In.C
Radiology · 84d
Cleared Jun 06, 1994
ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH
K941243 · JEQ
Oraline, Ltd.
Dental · 83d
Cleared Jun 06, 1994
NON-PRESCRIPTION SUNGLASSES
K941432 · HQY
Large River Industrial Co., Ltd.
Ophthalmic · 74d