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
79441–79464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2001
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · EHD
Planmeca Oy
Radiology · 35d
Cleared Jun 29, 2001
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
K011711 · KTT
Ebi, L.P.
Orthopedic · 25d
Cleared Jun 28, 2001
MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
K002409 · LGZ
Automatic Medical Technologies, Inc.
General Hospital · 325d
Cleared Jun 28, 2001
HOMMED OBSERVER, MODEL I
K003180 · DXN
Hommed, LLC
Cardiovascular · 260d
Cleared Jun 28, 2001
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
K003663 · BSZ
Spacelabs Medical, Inc.
Anesthesiology · 212d
Cleared Jun 28, 2001
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759 · GWM
Aesculap, Inc.
Neurology · 204d
Cleared Jun 28, 2001
AVIVA SYSTEM, MODEL SL 2020
K003999 · MWI
American Telecare, Inc.
Cardiovascular · 184d
Cleared Jun 28, 2001
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
K010422 · GWM
Innerspace, Inc.
Neurology · 136d
Cleared Jun 28, 2001
NEUROPACK MICRO, MODEL MED-9100A SERIES
K010590 · IKN
Nihon Kohden America, Inc.
Neurology · 121d
Cleared Jun 28, 2001
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
K011047 · MBF
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared Jun 28, 2001
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL...
K011061 · EGS
W&H Dentalwerk Buermoos GmbH
Dental · 83d
Cleared Jun 28, 2001
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE...
K011083 · HRX
Arthrocare Corp.
Orthopedic · 79d
Cleared Jun 28, 2001
MULTIRATE INFUSOR SV
K011317 · MEB
Baxter Healthcare Corp
General Hospital · 59d
Cleared Jun 28, 2001
READYSWIM
K011346 · MQL
Nidacon International AB
Obstetrics & Gynecology · 57d
Cleared Jun 28, 2001
MODIFICATION TO KSEA ENDOTIP SYSTEM
K011359 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 56d
Cleared Jun 28, 2001
SCORPIO CR SUPERFLEX TIBIAL INSERT
K011643 · JWH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jun 28, 2001
VACUETTE EVACUATED BLOOD COLLECTION TUBES
K011699 · JKA
Greiner Bio-One Vacuette North America
Chemistry · 27d
Cleared Jun 28, 2001
BIPAP PRO BI-LEVEL SYSTEM
K011714 · BZD
Respironics, Inc.
Anesthesiology · 24d
Cleared Jun 28, 2001
GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY
K011752 · IOR
Accufast, Inc.
Physical Medicine · 22d
Cleared Jun 28, 2001
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS
K011831 · DWM
Denver Biomedical, Inc.
Anesthesiology · 16d
Cleared Jun 27, 2001
ORTHOGENESIS LPS SYSTEM
K003182 · JWH
Depuy, Inc.
Orthopedic · 259d
Cleared Jun 27, 2001
EMS 3000
K010745 · IPF
Dan Med, Inc.
Physical Medicine · 106d
Cleared Jun 27, 2001
SIDEPORT PINCH CLAMP DEVICE
K010888 · FPA
Medivice Systems, Ltd.
General Hospital · 96d
Cleared Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
K010943 · JDQ
Synthes (Usa)
Orthopedic · 90d