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
88753–88776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1998
SYNTHES (USA) DHS HELIX SYSTEM
K981757 · JDO
Synthes (Usa)
Orthopedic · 59d
Cleared Jul 17, 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K981847 · LZO
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Jul 17, 1998
AMBU TUBECHECK
K981891 · BTR
Ambu, Inc.
Anesthesiology · 49d
Cleared Jul 17, 1998
WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW...
K981967 · MBI
Arthrotek/Biomet, Inc.
Orthopedic · 43d
Cleared Jul 17, 1998
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY...
K982085 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 32d
Cleared Jul 16, 1998
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS...
K972700 · KHJ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 393d
Cleared Jul 16, 1998
KNIGHTSTAR 335
K973004 · MNT
Puritan Bennett Corp.
Anesthesiology · 337d
Cleared Jul 16, 1998
CPR FILTERSHIELD
K980066 · BTM
Plasco, Inc.
Anesthesiology · 190d
Cleared Jul 16, 1998
OSCILLOMATE NIBP / SP02 EMS MONITOR
K980879 · DQA
Cas Medical Systems, Inc.
Anesthesiology · 129d
Cleared Jul 16, 1998
EQUINOXE
K980920 · ILJ
Bouvier Hydro, Inc.
Physical Medicine · 128d
Cleared Jul 16, 1998
SYNERGY LT
K981405 · GWF
Oxford Instruments, Plc.
Neurology · 87d
Cleared Jul 16, 1998
CERVIX COIL LATEX SHEATH
K981406 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 87d
Cleared Jul 16, 1998
LC POSITIONER
K981414 · JAA
Fischer Imaging Corp.
Radiology · 87d
Cleared Jul 15, 1998
FLOW-EZE BLUNT CANNULA (1999BC)
K972538 · FMI
Acacia, Inc.
General Hospital · 372d
Cleared Jul 15, 1998
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 359d
Cleared Jul 15, 1998
AURORA DIODE LASER SYSTEM
K974586 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 218d
Cleared Jul 15, 1998
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
K974736 · DWF
Heartport, Inc.
Cardiovascular · 208d
Cleared Jul 15, 1998
OCULOSTAT
K981235 · HNC
Laser Center Dev. Corp.
Ophthalmic · 103d
Cleared Jul 15, 1998
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT...
K981381 · DQX
Guidant Corp.
Cardiovascular · 90d
Cleared Jul 15, 1998
AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
K981533 · DRG
American Telecare, Inc.
Cardiovascular · 77d
Cleared Jul 15, 1998
NTI CLENCHING SUPPRESSION SYSTEM
K981546 · MQC
Heraeus Kulzer, Inc.
Dental · 76d
Cleared Jul 15, 1998
TYMPANOSTOMY TUBE
K981575 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 72d
Cleared Jul 15, 1998
VACUETTE MULTIPLE SAMPLE LUER ADAPTER
K981619 · FMI
Greiner Meditech, Inc.
General Hospital · 70d
Cleared Jul 14, 1998
C3 EXTERNAL MALE BLADDER CONTROL DEVICE
K974040 · FHA
Timm Research Co.
Gastroenterology & Urology · 263d