Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
63433–63456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2006
COLLOSS E BONE VOID FILLER
K051047 · MQV
Ossacur AG
Orthopedic · 317d
Cleared Mar 08, 2006
THEROX INFUSION CATHETER, MODEL INCA-1
K052637 · DQO
Therox, Inc.
Cardiovascular · 163d
Cleared Mar 08, 2006
DP240 240 HOUR DOPPLER PROBE
K052989 · DPT
Deltex Medical
Cardiovascular · 135d
Cleared Mar 08, 2006
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145,...
K053217 · DQY
St Jude Medical
Cardiovascular · 111d
Cleared Mar 08, 2006
TECHDEVICE GUIDEWIRE
K053251 · DQX
Techdevice Corporation
Cardiovascular · 107d
Cleared Mar 08, 2006
GSS PEDICLE SCREW SYSTEM
K053573 · MNH
GS Medical Co., Ltd.
Orthopedic · 76d
Cleared Mar 08, 2006
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
K060057 · FGE
Ev3, Inc.
Gastroenterology & Urology · 58d
Cleared Mar 08, 2006
AVANTICARE, MODEL SA4021
K060068 · INI
Lerado China Limited
Physical Medicine · 58d
Cleared Mar 08, 2006
RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A
K060077 · DXN
Real Tone Technology Corp.
Cardiovascular · 57d
Cleared Mar 08, 2006
ACTIVECARE ++ SYSTEM
K060146 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 48d
Cleared Mar 08, 2006
WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100
K060251 · IOR
Well Home Health Products Co.
Physical Medicine · 36d
Cleared Mar 08, 2006
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
K060264 · JIY
Dade Behring, Inc.
Chemistry · 35d
Cleared Mar 08, 2006
BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9
K060337 · FLE
Sauter AG
General Hospital · 26d
Cleared Mar 07, 2006
AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
K052202 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 207d
Cleared Mar 07, 2006
PROVISIONAL INLAY/ONLAY KIT
K052800 · EBG
Dmg USA, Inc.
Dental · 155d
Cleared Mar 07, 2006
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
K053442 · KGO
Regent Medical Americas, LLC
General Hospital · 88d
Cleared Mar 07, 2006
AIM ACCURACY IN MARKING SYSTEM
K053463 · ITX
Georgene Austria
Radiology · 84d
Cleared Mar 07, 2006
ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
K060103 · JOJ
Albert Browne , Ltd.
General Hospital · 53d
Cleared Mar 07, 2006
COMPE1 1 -PLY SURGICAL GOWNS
K060181 · FYA
Standard Textile Co., Inc.
General Hospital · 43d
Cleared Mar 07, 2006
MERITS MODEL E SERIES LIFT CHAIRS
K060212 · INO
Merits Health Products Co., Ltd.
Physical Medicine · 39d
Cleared Mar 07, 2006
CSS CANNULATED SCREW SYSTEM
K060428 · HWC
Orthohelix Surgical Designs, Inc.
Orthopedic · 14d
Cleared Mar 06, 2006
NOVABONE PUTTY - RESORBABLE BONE VOID FILLER
K051617 · MQV
Novabone Products, LLC
Orthopedic · 262d
Cleared Mar 06, 2006
NUVANCE* FACIAL REJUVENATION SYSTEM
K052953 · MXW
Ethicon, Inc.
General & Plastic Surgery · 137d
Cleared Mar 06, 2006
ALLOMATRIX CUSTOM
K053319 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 96d