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
78313–78336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2001
HOME HEALTH MONITORING SYSTEM
K010029 · DXN
Avid Care Corp.
Cardiovascular · 177d
Cleared Jun 29, 2001
ZURICH DISTRACTION SYSTEM
K010139 · MQN
KLS-Martin L.P.
Dental · 163d
Cleared Jun 29, 2001
LIPOMATIC
K010311 · QPB
Euromi S.A
General & Plastic Surgery · 148d
Cleared Jun 29, 2001
THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
K010692 · FMF
Spintech, Inc.
General Hospital · 113d
Cleared Jun 29, 2001
TRAM 2001 MODULE
K011000 · MHX
General Electric Medical Systems...
Cardiovascular · 87d
Cleared Jun 29, 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · GAM
Aesculap, Inc.
General & Plastic Surgery · 56d
Cleared Jun 29, 2001
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM
K011394 · EIH
Espe Dental AG
Dental · 53d
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