FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78841–78864 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 27, 2001
CYPRESS SYSTEM
K010950 · IYO
Acuson Corp.
Radiology · 90d
Cleared Jun 27, 2001
A-LINE AEP MONITOR
K010965 · OLW
Alaris Medical Systems, Inc.
Neurology · 86d
Cleared Jun 27, 2001
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
K010998 · HKX
Langham Ophthalmic Technologies
Ophthalmic · 85d
Cleared Jun 27, 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · KTT
Synthes (Usa)
Orthopedic · 83d
Cleared Jun 27, 2001
EASYBELL
K011075 · FCG
Biopsybell S.A.S.
Gastroenterology & Urology · 79d
Cleared Jun 27, 2001
CT/MASTER, VERSION 1.0
K011180 · JAK
Columbia Scientific, Inc.
Radiology · 71d
Cleared Jun 27, 2001
RESTORE-PF VIC
K011295 · EBF
First Scientific Limited
Dental · 58d
Cleared Jun 27, 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · MAI
Smith & Nephew, Inc.
Orthopedic · 58d