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
83185–83208 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2000
LOCATOR IMPLANT ANCHOR
K994257 · DZE
Zest Anchors, Inc.
Dental · 92d
Cleared Mar 17, 2000
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
K994280 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 88d
Cleared Mar 17, 2000
SOLO ORTHO 2
K994309 · DYH
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Mar 17, 2000
UMBILICAL CORD CLAMP
K994367 · HFW
Medical Sales Co.
Obstetrics & Gynecology · 81d
Cleared Mar 16, 2000
IMAGE X-70 PLUS DENTAL X-RAY UNIT
K000551 · EHD
Medical Device Consultants, Inc.
Radiology · 27d
Cleared Mar 16, 2000
GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING...
K000695 · IYO
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Mar 16, 2000
MEMOTHERM COLORECTAL STENT
K990504 · MQR
C.R. Bard, Inc.
Gastroenterology & Urology · 393d
Cleared Mar 16, 2000
125-IMPLANT SEEDS, MODEL STM1250
K991881 · KXK
Sourcetech Medical, LLC
Radiology · 288d
Cleared Mar 16, 2000
MSP M/K BLADE
K993122 · HNO
Medical Sterile Products, Inc.
Ophthalmic · 178d
Cleared Mar 16, 2000
FRESENIUS 2008K
K994267 · KDI
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared Mar 16, 2000
FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
K994287 · LNH
Fonar Corp.
Radiology · 87d
Cleared Mar 16, 2000
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
K994366 · MEH
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Mar 16, 2000
BABY FACE
K994385 · IYO
Sonora Medical Systems
Radiology · 79d
Cleared Mar 16, 2000
RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
K994387 · GZJ
Woodside Biomedical, Inc.
Neurology · 79d
Cleared Mar 15, 2000
POSITUBE
K000045 · BTR
Paraproducts, Inc.
Anesthesiology · 68d
Cleared Mar 15, 2000
ACL 9000 SYSTEM
K000053 · JPA
Instrumentation Laboratory CO
Hematology · 68d
Cleared Mar 15, 2000
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
K000066 · HRS
Synthes (Usa)
Orthopedic · 65d
Cleared Mar 15, 2000
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
K000086 · KGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Mar 15, 2000
SYNTHES ANTERIOR CSLP SYSTEM
K000536 · KWQ
Synthes Spine
Orthopedic · 28d
Cleared Mar 15, 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538 · LPH
Biomet, Inc.
Orthopedic · 27d
Cleared Mar 15, 2000
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
K990897 · CAF
Puritan-Bennett Ireland, Ltd.
Anesthesiology · 363d
Cleared Mar 15, 2000
IN-LINE HEMOSTASIS VALVE
K990975 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 358d
Cleared Mar 15, 2000
SIGHTSURE OPERATION INDICATOR, MODEL SS301
K993358 · KNT
Medevices, Inc.
Gastroenterology & Urology · 161d
Cleared Mar 15, 2000
DATEX-OHMEDA TONOMETRY MODULE M-TONO
K993656 · CCK
Datex-Ohmeda, Inc.
Anesthesiology · 138d