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
89137–89160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 1998
FUTURELASE 3000/3002 ERBIUM LASER SYSTEM
K974641 · GEX
Buckman Co., Inc.
General & Plastic Surgery · 175d
Cleared Jun 08, 1998
PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM
K974880 · IYO
Perception, Inc.
Radiology · 160d
Cleared Jun 08, 1998
MUCHECK MONITOR UNIT VALIDATION PROGRAM
K980904 · IYE
Medical Dosimetry Services, Inc.
Radiology · 90d
Cleared Jun 08, 1998
MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
K980946 · FFX
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 87d
Cleared Jun 08, 1998
IIRAD DIRECTRAY OPERATOR CONSOLE
K980970 · LLZ
Sterling Diagnostic Imaging, Inc.
Radiology · 84d
Cleared Jun 08, 1998
E.CAM LSO 311 PET/SPECT SYSTEM
K981027 · KPS
Cti Pet Systems, Inc.
Radiology · 81d
Cleared Jun 08, 1998
AMY
K981216 · JFJ
Abbott Laboratories
Chemistry · 66d
Cleared Jun 08, 1998
OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND...
K981543 · EOQ
The Olympus Optical Co.
Ear, Nose, Throat · 39d
Cleared Jun 08, 1998
IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM
K981560 · JWH
Implex Corp.
Orthopedic · 38d
Cleared Jun 08, 1998
IRON
K981581 · CFM
Abbott Laboratories
Chemistry · 35d
Cleared Jun 08, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K981622 · JJX
Dade Behring, Inc.
Chemistry · 32d
Cleared Jun 08, 1998
CO2
K981840 · KHS
Abbott Laboratories
Chemistry · 13d
Cleared Jun 05, 1998
PERACIDIN DIALYZER REPROCESSING CONCENTRATE
K962959 · MED
Hdc Medical, Inc.
General Hospital · 675d
Cleared Jun 05, 1998
FLUTTER D
K972859 · BYI
Bradstreet Clinical Research Assoc.,...
Anesthesiology · 305d
Cleared Jun 05, 1998
PROVI CEMENT
K973201 · EMA
S & C Polymer GmbH
Dental · 283d
Cleared Jun 05, 1998
MACH-SIGMA HANDPIECE, ULTRAPUSH
K980162 · EFB
Nsk Nakanishi, Inc.
Dental · 140d
Cleared Jun 05, 1998
SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K980882 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Jun 05, 1998
LACTOSORB PANELS AND FASTENERS
K980927 · JEY
Biomet, Inc.
Dental · 86d
Cleared Jun 05, 1998
DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES
K980929 · KGO
Ansell Perry
General Hospital · 85d
Cleared Jun 05, 1998
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
K980996 · KHS
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Jun 05, 1998
MILLS COLUMELLA PROSTHESIS
K981088 · ETA
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 72d
Cleared Jun 05, 1998
POWDERED NITRILE EXAMINATION GLOVES
K981133 · LZA
Servicom Services Sdn Bhd
General Hospital · 77d
Cleared Jun 05, 1998
ETEST CIPROFLOXACIN
K981138 · JWY
Ab Biodisk
Microbiology · 67d
Cleared Jun 05, 1998
RUSCH BLAKEMORE 3 LUMEN, STERILE
K981203 · KNT
Rusch Intl.
Gastroenterology & Urology · 64d