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
93985–94008 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 1997
PHILIPS INTEGRIS H5000
K971365 · IZI
Philips Medical Systems North...
Radiology · 30d
Cleared May 14, 1997
MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE
K971452 · IZZ
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared May 13, 1997
MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT
K964132 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 210d
Cleared May 13, 1997
CHASE LEFT VENT SAFETY VALVE
K964391 · DWF
Chase Medical, Inc.
Cardiovascular · 190d
Cleared May 13, 1997
MBI ILLUMINATED RETINAL PICK
K964405 · MPA
M.B. Industries, Inc.
Ophthalmic · 190d
Cleared May 13, 1997
MBI CO-AXIAL ILLUMINATED RETINAL PICK
K964553 · MPA
M.B. Industries, Inc.
Ophthalmic · 181d
Cleared May 13, 1997
NUVO-LASE 660 LASER SYSTEM
K970667 · GEX
American Laser Medical
General & Plastic Surgery · 78d
Cleared May 13, 1997
AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
K970699 · HQY
Yeong Jiuh Corp.
Ophthalmic · 77d
Cleared May 13, 1997
QUICKPAC II ONE STEP METHAMPHETAMINE TEST
K970724 · DKZ
Drial Consultants, Inc.
Toxicology · 75d
Cleared May 13, 1997
CHASE AORTIC PERFUSION CANNULA
K970914 · DWF
Chase Medical, Inc.
Cardiovascular · 62d
Cleared May 13, 1997
CHASE CORONARY OSTIAL PERFUSION CANNULA
K971041 · DWF
Chase Medical, Inc.
Cardiovascular · 53d
Cleared May 13, 1997
MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS
K971208 · GAM
Medline Industries, Inc.
General & Plastic Surgery · 41d
Cleared May 13, 1997
SUNGLASSES
K971412 · HQY
Team Chien Industrial Co., Ltd.
Ophthalmic · 27d
Cleared May 12, 1997
ODONT HEX SYSTEM
K961631 · DZE
Odontit S.A.
Dental · 378d
Cleared May 12, 1997
MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE
K963340 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 259d
Cleared May 12, 1997
MODEL DX MICRO COMPUTER CONTROL
K970094 · ITI
Invacare Respiratory Corp.
Physical Medicine · 122d
Cleared May 12, 1997
INNOFLOUR CALIBRATOR REAGENT SET
K970509 · DLJ
Oxis Intl., Inc.
Toxicology · 90d
Cleared May 12, 1997
INNOFLOUR TOPIRAMATE REAGENT SET
K970510 · MSL
Oxis Intl., Inc.
Toxicology · 90d
Cleared May 12, 1997
INNOFLUOR TOPIRAMATE CONTROL SET
K970517 · LAS
Oxis Intl., Inc.
Toxicology · 90d
Cleared May 12, 1997
MEDISYSTEMS TRANDUCER PROTECTOR
K970536 · FIB
Medisystems Corp.
Gastroenterology & Urology · 89d
Cleared May 12, 1997
SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
K970556 · CGA
Lifescan, Inc.
Chemistry · 88d
Cleared May 12, 1997
DYNAMIC WEDGE
K970564 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 88d
Cleared May 12, 1997
BRAINLAB MICRO MULTI-LEAF COLLIMATOR
K970586 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 87d
Cleared May 12, 1997
GE ADVANTAGE DIGITIZER WORKSTATION
K970628 · LMD
Ge Medical Systems, Inc.
Radiology · 82d