FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
100993–101016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1995
SCREW IMPLANTS, GRADE 3
K953234 · DZE
The Implant Center of the Palm Beaches
Dental · 120d
Cleared Nov 08, 1995
AIR ENTRAINER 900RT008
K953711 · BZR
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 91d
Cleared Nov 08, 1995
AUTOJECT MINI
K953735 · KZH
Owen Mumford USA, Inc.
General Hospital · 90d
Cleared Nov 08, 1995
DG EXAMINER PLUS
K953799 · OLT
Medelec , Ltd.
Neurology · 86d
Cleared Nov 08, 1995
DISPOSABLE PROPHY HANDPIECE
K954012 · EFB
Denticator Intl., Inc.
Dental · 75d
Cleared Nov 08, 1995
GENERAL HYGIENE KIT
K954068 · KHR
Physician Industries, Inc.
Dental · 70d
Cleared Nov 08, 1995
SORBSAN PLUS TOPICAL WOUND DRESSING
K954230 · KMF
Dow Hickam Pharmaceuticals, Inc.
General & Plastic Surgery · 58d
Cleared Nov 08, 1995
MARLENE STOCKINGS & TIGHTS
K954295 · DWL
Professional Products, Inc.
General Hospital · 55d
Cleared Nov 08, 1995
RITE-ANGLE DISPOSABLE PROPHY ANGLES
K954802 · EGS
Ash-USA
Dental · 20d
Cleared Nov 07, 1995
EXCEL EMG
K941144 · IKN
Excel Tech. , Ltd.
Neurology · 607d
Cleared Nov 07, 1995
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K950275 · MAI
Zimmer, Inc.
Orthopedic · 288d
Cleared Nov 07, 1995
EDM
K951369 · DPW
Deltex Medical
Cardiovascular · 225d
Cleared Nov 07, 1995
MIKRO-TIP ANGIOGRAPHIC CATHETER
K952773 · DQO
Millar Instruments, Inc.
Cardiovascular · 144d
Cleared Nov 07, 1995
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760 · DQX
Cordis Corp.
Cardiovascular · 88d
Cleared Nov 07, 1995
SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM
K953779 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 85d
Cleared Nov 07, 1995
MODELS 5866-45 AND 5866-46 SIZING SLEEVE
K954085 · DTB
Medtronic Vascular
Cardiovascular · 71d
Cleared Nov 07, 1995
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)
K954913 · DQX
Cardio Metrics, Inc.
Cardiovascular · 35d
Cleared Nov 06, 1995
VENTANA BLUE DETECTION KIT
K940424 · DEH
Ventana Medical Systems, Inc.
Immunology · 644d
Cleared Nov 06, 1995
COAMATIC FACTOR VIII
K943225 · GGP
Pharmacia Hepar, Inc.
Hematology · 488d
Cleared Nov 06, 1995
COHORT(TM) ANTERIOR PLATE SYSTEM (APS)
K950011 · KWQ
Cohort Medical Products Group, Inc.
Orthopedic · 307d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM
K950470 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM
K950471 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM
K950474 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
K950477 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d