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
95881–95904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1996
OVATION LINEAR
K963820 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION AGC-1
K963821 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION AGC-3
K963822 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 25, 1996
CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE
K951567 · ITX
Cardio Metrics, Inc.
Radiology · 570d
Cleared Oct 25, 1996
GLUCOSE (HEXOKINASE) KIT
K953210 · CFR
Randox Laboratories, Ltd.
Chemistry · 473d
Cleared Oct 25, 1996
SERVO VENTILATOR 300 COMPUTER INTERFACE
K960010 · CBK
Siemens Elema AB
Anesthesiology · 297d
Cleared Oct 25, 1996
CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
K960159 · JXG
Cordis Corp.
Neurology · 288d
Cleared Oct 25, 1996
SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
K960168 · CBK
Siemens Elema AB
Anesthesiology · 283d
Cleared Oct 25, 1996
KSEA MODEL 383320 20 ANGIOMAT
K960486 · DQI
Karl Storz Endoscopy
General Hospital · 266d
Cleared Oct 25, 1996
RAPID ELECTROPHORESIS ANALYZER
K960571 · JHO
Helena Laboratories
Chemistry · 260d
Cleared Oct 25, 1996
SLS-CT
K960985 · JAK
Bio-Imaging Research, Inc.
Radiology · 239d
Cleared Oct 25, 1996
OSTEOMED MSS
K961418 · DZL
Osteomed Corp.
Dental · 196d
Cleared Oct 25, 1996
VIEWSEND MEDICAL MODEL 1200
K962225 · LMD
Klt Telecom, Inc.
Radiology · 137d
Cleared Oct 25, 1996
STA - LIATEST VWF TEST KIT
K962675 · GJT
American Bioproducts Co.
Hematology · 108d
Cleared Oct 25, 1996
REMBRANDT SYSTEM
K962865 · FLS
Airsep Corp.
Anesthesiology · 94d
Cleared Oct 25, 1996
PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
K962924 · BZH
Healthscan Products, Inc.
Anesthesiology · 88d
Cleared Oct 25, 1996
OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
K962925 · FGE
Olympus America, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 25, 1996
CORDIS STABILIZER PLUS XS
K962932 · DQX
Cordis Corp.
Cardiovascular · 88d
Cleared Oct 25, 1996
OPART MRT-600
K962933 · LNH
Toshiba America Mri, Inc.
Radiology · 88d
Cleared Oct 25, 1996
EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
K962938 · FOZ
Excelsior Medical Corp.
General Hospital · 88d
Cleared Oct 25, 1996
CERALAS G ND
K962948 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 88d
Cleared Oct 25, 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 77d
Cleared Oct 25, 1996
STEALTHSTATION SYSTEM
K963173 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 72d
Cleared Oct 25, 1996
PROSYS SAMEC LA
K963265 · EXJ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 66d