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
102481–102504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1995
ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES
K945254 · GEI
Endotec, Inc.
General & Plastic Surgery · 221d
Cleared Jun 06, 1995
STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
K945956 · LJS
Strato Medical Corp.
General Hospital · 182d
Cleared Jun 06, 1995
VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM
K946177 · GEI
Valleylab, Inc.
General & Plastic Surgery · 169d
Cleared Jun 06, 1995
SENSIMATIC 500SE
K950239 · EKZ
Parkell, Inc.
Dental · 137d
Cleared Jun 06, 1995
PRESSUREGUARD IV
K951112 · FNM
Span-America Medical Systems, Inc.
General Hospital · 88d
Cleared Jun 06, 1995
WELCH ALLYN VIDEO OPHTHALMOSCOPE
K951210 · HLI
Welch Allyn, Inc.
Ophthalmic · 81d
Cleared Jun 06, 1995
SURGACTIVATOR
K951569 · LJH
Deschutes Medical Products, Inc.
Gastroenterology & Urology · 63d
Cleared Jun 06, 1995
UNIVEC NONREUSABLE LOCKING SYRINGE
K951619 · FMF
Univec, Inc.
General Hospital · 71d
Cleared Jun 06, 1995
TYTIN R
K951663 · EJJ
Kerr Corporation (Danbury)
Dental · 57d
Cleared Jun 06, 1995
PRIMALLOR 1
K951784 · EJT
Degussa Corp.
Dental · 50d
Cleared Jun 06, 1995
PRIMALLOR 2
K951785 · EJT
Degussa Corp.
Dental · 50d
Cleared Jun 06, 1995
FAIRY WORLD INC
K951992 · HQY
Fairy World, Inc.
Ophthalmic · 39d
Cleared Jun 06, 1995
V-GNATHOS PLUS
K952122 · EJT
Metalor Dental USA Corp.
Dental · 32d
Cleared Jun 05, 1995
NH-2002
K932050 · QJQ
New Horizon Health Care
Neurology · 769d
Cleared Jun 05, 1995
HEARTRAC ECG MONITORING SYSTEM
K934913 · QYW
Cardiac Telecom Corp.
Cardiovascular · 598d
Cleared Jun 05, 1995
PROTECTIVE SHORTS
K943948 · DXC
Y. Daneshvar, M.D.
Cardiovascular · 291d
Cleared Jun 05, 1995
VALLEYLAB FORCE FX
K944602 · GEI
Valleylab, Inc.
General & Plastic Surgery · 259d
Cleared Jun 05, 1995
PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING
K945379 · DQX
Boston Scientific Corp
Cardiovascular · 215d
Cleared Jun 05, 1995
DECA DERMATOME (MICROMOTOR SYSTEM)
K945594 · GFD
Depuy Intl., Ltd.
General & Plastic Surgery · 203d
Cleared Jun 05, 1995
BRAINLAB MASK SYSTEM
K945903 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 185d
Cleared Jun 05, 1995
THIN-FILM CARDIAC GATING CABLE
K946085 · LNH
General Electric Co.
Radiology · 174d
Cleared Jun 05, 1995
KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION
K946332 · EQJ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 158d
Cleared Jun 05, 1995
COMPACT 7600
K950781 · JAA
Ge Dec Medical Systems
Radiology · 104d
Cleared Jun 05, 1995
NATURE'S CRADLE
K951024 · FMS
Infant Advantage, Inc.
General Hospital · 91d