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
76753–76776 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2002
METAVISION CLINICAL INFORMATION SYSTEM
K012349 · MWI
Imdsoft, Ltd.
Cardiovascular · 189d
Cleared Jan 29, 2002
REMSTAR AUTO CPAP SYSTEM
K012554 · BZD
Respironics, Inc.
Anesthesiology · 174d
Cleared Jan 29, 2002
CIC-C1Q EIA
K012576 · DAK
American Laboratory Products Co., Ltd.
Immunology · 173d
Cleared Jan 29, 2002
THERMAGE THERMACOOL TC SYSTEM
K013639 · GEI
Thermage, Inc.
General & Plastic Surgery · 85d
Cleared Jan 29, 2002
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER...
K013641 · GEI
Senorx, Inc.
General & Plastic Surgery · 85d
Cleared Jan 29, 2002
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K013665 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 84d
Cleared Jan 29, 2002
RHODIA BITE REGISTRATION MATERIAL
K013859 · ELW
Rhodia, Inc.
Dental · 69d
Cleared Jan 29, 2002
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
K013959 · DKB
Bayer Diagnostics Corp.
Toxicology · 60d
Cleared Jan 29, 2002
JETSONIC 2000
K014245 · KOJ
Deldent , Ltd.
Dental · 34d
Cleared Jan 29, 2002
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
K020012 · DQO
Boston Scientific/Medi-Tech
Cardiovascular · 26d
Cleared Jan 29, 2002
COOLBLU2 DENTAL RESIN CURING DEVICE
K020171 · EBZ
Dental Systems.Com, Inc.
Dental · 12d
Cleared Jan 28, 2002
SALINE IV FLUSH SYRINGE
K002142 · FOZ
Emt-Rx
General Hospital · 560d
Cleared Jan 28, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K010378 · MQP
Implex Corp.
Orthopedic · 354d
Cleared Jan 28, 2002
DEPUY FEMORAL HEADS
K011533 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 255d
Cleared Jan 28, 2002
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM
K012089 · DQK
Catheffects, LLC
Cardiovascular · 207d
Cleared Jan 28, 2002
EXCITE SELF ETCH
K013584 · KLE
Ivoclar Vivadent, Inc.
Dental · 90d
Cleared Jan 28, 2002
MEDIPORT 2000 MOBILE
K013585 · BTA
Servox Medizintechnik GmbH
General & Plastic Surgery · 90d
Cleared Jan 28, 2002
BCC GAMMA CAMERA
K013667 · KPS
Is2 Research, Inc.
Radiology · 83d
Cleared Jan 28, 2002
HI-ART SYSTEM
K013673 · MUJ
Tomo Therapy, Inc.
Radiology · 83d
Cleared Jan 28, 2002
JOBST READY-TO-WEAR GAUNTLET
K013852 · DWL
Bsn-Jobst, Inc.
General Hospital · 69d
Cleared Jan 28, 2002
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
K013922 · LLZ
Barco N.V.
Radiology · 62d
Cleared Jan 28, 2002
MINI SHOPPER
K013927 · INI
Shoprider Intl., Inc.
Physical Medicine · 61d
Cleared Jan 28, 2002
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
K013938 · KHP
Diametrics Medical, Inc.
Chemistry · 61d
Cleared Jan 28, 2002
WIENER LAB. ALP 405
K013983 · CJE
Wiener Laboratories Saic
Chemistry · 56d