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
104785–104808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 1995
ENDOCARE CRYOTHERAPY SYSTEM
K942299 · GEH
Cytocare, Inc.
General & Plastic Surgery · 252d
Cleared Jan 19, 1995
NEONATAL RESTRAINT AND COMFORT SYSTEMS
K943017 · FRP
K.Bowmed, Inc.
General Hospital · 209d
Cleared Jan 19, 1995
SENTRY TOTAL HIP
K945089 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
K945090 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
P.C.A.PRIMARY HIP- CEMENTLESS USE
K945092 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
P.C.A. E-SERIES HIP- CEMENTLESS USE
K945093 · LZO
Howmedica, Inc.
Orthopedic · 94d
Cleared Jan 19, 1995
HNR-PC HIP
K945094 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
APC FEMORAL COMPONENT
K945095 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
CDH HIP STEM
K945096 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND...
K945202 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 86d
Cleared Jan 19, 1995
NASAL SPLINT
K945555 · LYA
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 66d
Cleared Jan 19, 1995
MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT
K945707 · IZL
Minxray, Inc.
Radiology · 59d
Cleared Jan 19, 1995
MODELS 4100 AND 4300 MULTITHERAPY
K945954 · JFB
Spinalight, Inc.
Physical Medicine · 44d
Cleared Jan 18, 1995
STERILE EXTRA PROTECION SURGEON'S GLOVES
K922979 · KGO
Ansell Malaysia Sdn Bhd
General Hospital · 940d
Cleared Jan 18, 1995
HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM
K930836 · KTT
Howmedica Corp.
Orthopedic · 700d
Cleared Jan 18, 1995
EMG TRAINER
K935853 · HCC
Unitech
Neurology · 406d
Cleared Jan 18, 1995
AGILANCE-GOLDEN SPOONS
K936178 · ISA
Oismuller & Partner Keg
Physical Medicine · 387d
Cleared Jan 18, 1995
KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K936274 · JWH
Kirschner Medical Corp.
Orthopedic · 384d
Cleared Jan 18, 1995
OPEN LAPAROSCOPY TROCAR CONE SYSTEM
K941222 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 310d
Cleared Jan 18, 1995
CTS RELIEF KIT
K941651 · HRX
Linvatec Corp.
Orthopedic · 288d
Cleared Jan 18, 1995
HEARTPRINT
K942862 · DSH
Medata, Inc.
Cardiovascular · 215d
Cleared Jan 18, 1995
STERISEAL OPHTHALMIC CANNULA
K943932 · HMX
Pharma-Plast, Ltd.
Ophthalmic · 159d
Cleared Jan 18, 1995
IL TEST THEOPHYLLINE
K943979 · KLS
Instrumentation Laboratory CO
Toxicology · 225d
Cleared Jan 18, 1995
IL TEST PHENOBARBITAL CALIBRATORS
K943981 · DLZ
Instrumentation Laboratory CO
Toxicology · 225d