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
94033–94056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 27, 1997
POINT OF USE II SHARPS-A-GATOR
K964387 · MMK
Graphic Controls Corp.
General Hospital · 143d
Cleared Mar 27, 1997
TEETHMATE F-1
K965091 · EBC
Kuraray Company, Ltd.
Dental · 98d
Cleared Mar 27, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
K970076 · FPA
Nipro Medical Corp.
General Hospital · 77d
Cleared Mar 27, 1997
JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES
K970111 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 73d
Cleared Mar 27, 1997
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
K970433 · ELW
Dentsply Intl.
Dental · 50d
Cleared Mar 27, 1997
EKONIC DENTAL/MEDICAL MASK (MD 610)
K970440 · FXX
Ekonic Company, Ltd.
General Hospital · 50d
Cleared Mar 27, 1997
POLY-MED
K970625 · LYY
Shinemound Enterprise, Inc.
General Hospital · 36d
Cleared Mar 27, 1997
PNEUMO-MATIC INSUFFLATION NEEDLE
K970788 · FHO
Apple Medical Corp.
Gastroenterology & Urology · 23d
Cleared Mar 27, 1997
CONVERTORS IMPERVIOUS SHOE COVERS
K970815 · FXP
Allegiance Healthcare Corp.
General Hospital · 21d