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
94537–94560 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1997
ARTOSCAN M
K963262 · LNH
Biosound, Inc.
Radiology · 220d
Cleared Mar 28, 1997
AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
K963293 · MSA
Augustine Medical, Inc.
General & Plastic Surgery · 219d
Cleared Mar 28, 1997
FOCUS PV BALLOON DILATATION CATHETER
K963688 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 193d
Cleared Mar 28, 1997
PARAMAX TRIGLYCERID REAGENT
K964346 · CDT
Dade Intl., Inc.
Chemistry · 148d
Cleared Mar 28, 1997
FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC...
K964441 · KNF
Gynecare Innovation Center
Obstetrics & Gynecology · 142d
Cleared Mar 28, 1997
CRYOGEN CRYOSURGICAL SYSTEM
K964971 · GEH
Cryogen, Inc.
General & Plastic Surgery · 106d
Cleared Mar 28, 1997
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
K965214 · DTX
Coeur Laboratories, Inc.
Cardiovascular · 88d
Cleared Mar 28, 1997
PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE...
K965239 · CBN
Accutron, Inc.
Anesthesiology · 87d
Cleared Mar 28, 1997
GYREX 2T-PRESTIGE
K970005 · LNI
Elscint, Inc.
Radiology · 85d
Cleared Mar 28, 1997
FAST TRACT TRANSTRACHEAL PROCEDURE KIT
K970018 · LRC
L.W. Ward and Assoc., Inc.
Ear, Nose, Throat · 85d
Cleared Mar 28, 1997
UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
K970046 · KHA
Accutron, Inc.
Anesthesiology · 81d
Cleared Mar 28, 1997
ULTRATOMERX
K970053 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 80d
Cleared Mar 28, 1997
HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE...
K970130 · GEI
Medtrex, Inc.
General & Plastic Surgery · 72d
Cleared Mar 28, 1997
E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH
K970140 · GEI
Valleylab, Inc.
General & Plastic Surgery · 72d
Cleared Mar 28, 1997
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
K970170 · HDB
Richard G. Lindsay
Obstetrics & Gynecology · 78d
Cleared Mar 28, 1997
SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
K970244 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 65d
Cleared Mar 28, 1997
REXTON MODEL 48 AND 49PP
K970537 · ESD
Rexton, Inc.
Ear, Nose, Throat · 44d
Cleared Mar 28, 1997
AESCULAP MODULAR MONOPOLAR ELECTRODES
K970541 · GEI
Aesculap, Inc.
General & Plastic Surgery · 44d
Cleared Mar 28, 1997
MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
K970565 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Mar 28, 1997
B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
K970737 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 28d
Cleared Mar 28, 1997
DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · DXE
Applied Medical Resources
Cardiovascular · 25d
Cleared Mar 28, 1997
SELECTA-TIP LAPAROSCOPIC SCISSORS
K970826 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 22d
Cleared Mar 28, 1997
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
K971057 · GCT
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 4d
Cleared Mar 27, 1997
INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
K964021 · HCG
Baxter Edwards
Neurology · 171d