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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68329–68352 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2004
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
K040694 · HCG
Micro Therapeutics, Inc.
Neurology · 8d
Cleared Mar 24, 2004
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND...
K032657 · NBW
Home Diagnostics, Inc.
Chemistry · 209d
Cleared Mar 24, 2004
MICRO TARGETING ELECTRODE
K033173 · GZL
FHC, Inc.
Neurology · 175d
Cleared Mar 24, 2004
ENDOBOY
K033644 · GCJ
Geyser S.A.
General & Plastic Surgery · 125d
Cleared Mar 24, 2004
3I PATIENT-SPECIFIC OVERDENTURE BAR
K034035 · NHA
Implant Innovations, Inc.
Dental · 86d
Cleared Mar 24, 2004
INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
K040050 · LLZ
Ge Medical Systems Navigation and...
Radiology · 72d
Cleared Mar 24, 2004
MEGVISION, MODEL EQ1000C SERIES
K040051 · OLX
Eagle Technology, Inc.
Neurology · 72d
Cleared Mar 24, 2004
EASY LOOP, MODEL EZL-01
K040110 · EZP
Tools For Surgery, LLC
Gastroenterology & Urology · 64d
Cleared Mar 24, 2004
IFL PROFESSIONAL SYSTEM, MODEL C100
K040156 · GEX
Cyden Limited
General & Plastic Surgery · 61d
Cleared Mar 24, 2004
ACCESS DHEA-S REAGENT ASSAY
K040181 · JKC
Beckman Coulter, Inc.
Chemistry · 57d
Cleared Mar 24, 2004
MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6
K040244 · GCJ
The Microoptical Corporation
General & Plastic Surgery · 50d
Cleared Mar 24, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
K040245 · JIX
Roche Diagnostics Corp.
Chemistry · 50d
Cleared Mar 24, 2004
SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS
K040398 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 36d
Cleared Mar 24, 2004
MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
K040521 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 23d
Cleared Mar 24, 2004
CARDIOMD-AC
K040616 · KPS
Danish Diagnostic Development A/S
Radiology · 15d
Cleared Mar 23, 2004
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS:...
K024213 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 459d
Cleared Mar 23, 2004
SYDNEY IVF PVP
K031304 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 334d
Cleared Mar 23, 2004
ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS
K033109 · MQP
Scient'X
Orthopedic · 175d
Cleared Mar 23, 2004
ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
K033149 · KPL
Ultimate Concepts, Inc.
Gastroenterology & Urology · 175d
Cleared Mar 23, 2004
ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4
K034045 · MQN
Oral Osteodistraction, L.P.
Dental · 85d
Cleared Mar 23, 2004
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
K040064 · KTT
Newmedical Technology, Inc.
Orthopedic · 70d
Cleared Mar 23, 2004
BONE-LOK HP WASHER
K040250 · HTN
Triage Medical, Inc.
Orthopedic · 50d
Cleared Mar 23, 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
K040258 · KTT
Synthes (Usa)
Orthopedic · 48d
Cleared Mar 23, 2004
SUSTAIN RADIOLUCENT SPACER
K040284 · MQP
Globus Medical, Inc.
Orthopedic · 46d