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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133513–133536 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1988
CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS
K883239 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 81d
Cleared Oct 21, 1988
VALLEYLAB I.V. ADMINISTRATION SETS
K883318 · FPA
Valleylab, Inc.
General Hospital · 77d
Cleared Oct 21, 1988
CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100
K883534 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 64d
Cleared Oct 21, 1988
CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170
K883644 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 57d
Cleared Oct 21, 1988
MOUTH-TO-MASK VENTILATORY ADJUNCT
K883766 · KGB
Medic One
Anesthesiology · 45d
Cleared Oct 21, 1988
CARETEX CENTRAL SUPPLY WRAP
K883802 · FRG
James River Corp.
General Hospital · 44d
Cleared Oct 21, 1988
GENESIS 180
K883863 · IXR
Fischer Imaging Corp.
Radiology · 38d
Cleared Oct 21, 1988
MODIFIED FEF(TM) END-TIDAL CO2 DETECTOR
K884080 · CCK
Fenem, Inc.
Anesthesiology · 24d
Cleared Oct 21, 1988
MICRO-X 100CP
K884134 · IZO
Fischer Imaging Corp.
Radiology · 21d
Cleared Oct 21, 1988
COMFORT STRAP
K884149 · CAT
Comfort Strap Co.
Anesthesiology · 18d
Cleared Oct 20, 1988
JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS
K882234 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 146d
Cleared Oct 20, 1988
KISS OF MINT(TM) NON-LUBRICATED CONDOM
K882389 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 132d
Cleared Oct 20, 1988
SAMUELSON SCREWLOC CUP
K882671 · KWA
Protek, Inc.
Orthopedic · 114d
Cleared Oct 20, 1988
EXTRAVAKIT FOR RADIOLOGICAL APPLICATIONS
K883220 · FMF
Cancer Technologies, Inc.
General Hospital · 83d
Cleared Oct 20, 1988
CODMAN NEUROLASE LASER SYSTEM
K883642 · GEX
I.L. Med, Inc.
General & Plastic Surgery · 58d
Cleared Oct 20, 1988
TDX AMPHETAMINE/METHAMPHETAMINE II
K883707 · DKZ
Abbott Laboratories
Chemistry · 51d
Cleared Oct 20, 1988
BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN
K883799 · EBI
Austenal Dental, Inc.
Dental · 43d
Cleared Oct 20, 1988
BALLET STERILE DISPOSABLE ELECTROLYSIS
K883892 · KCW
Synoptic Products
General & Plastic Surgery · 36d
Cleared Oct 20, 1988
TANGENT II
K883974 · IZZ
Fischer Imaging Corp.
Radiology · 30d
Cleared Oct 19, 1988
KONTRON PULSE OXIMETER 7840
K873624 · DQA
Kontron Instruments, Inc.
Anesthesiology · 407d
Cleared Oct 19, 1988
CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS
K873772 · DTB
Cordis Leads, Inc.
Cardiovascular · 399d
Cleared Oct 19, 1988
TCT-300S COMPUTED TOMO. (CT) X-RAY SYSTEM FOR EXAM
K881305 · JAK
Toshiba Medical Systems
Radiology · 205d
Cleared Oct 19, 1988
WILSON BIOMEDICAL CORONARY GUIDING CATHETER
K881793 · DQY
Wilson Biomedical, Inc.
Cardiovascular · 176d
Cleared Oct 19, 1988
PULSED FLUOROSCOPIC CONTROL MODEL:PF-02
K882358 · IZI
U.S. Imaging, Inc.
Radiology · 134d