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
128281–128304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 1989
EPI-CATH(TM) EPIDURAL CATHETER
K895204 · BSO
Abbott Laboratories
Anesthesiology · 90d
Cleared Nov 15, 1989
BACTERIAL AND VIRAL FILTER
K895233 · CAH
F.L.W. Plastics, Inc.
General Hospital · 86d
Cleared Nov 15, 1989
C.P.A.P. VALVE AND C.P.P.A. KIT
K895360 · BYE
Ballard Medical Products
Anesthesiology · 79d
Cleared Nov 15, 1989
V*S*R(TM) SCOPE
K895545 · LDE
Vsr Enterprises Corp.
Cardiovascular · 63d
Cleared Nov 15, 1989
DIGICAM LHP (VIDEO INTERFACE OPTION)
K895668 · LMC
Siemens Gammasonics, Inc.
Radiology · 56d
Cleared Nov 15, 1989
MODEL 8750 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENE.
K895841 · GEI
Everest Medical Corp.
General & Plastic Surgery · 44d
Cleared Nov 14, 1989
SMYLON (DENTAL STAIN ERASER)
K891338 · MAU
The Smylon Co.
Dental · 246d
Cleared Nov 14, 1989
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
K893041 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 204d
Cleared Nov 14, 1989
POWERED EYE WASH
K893829 · MSI
Sacks Model Makers
Ophthalmic · 174d
Cleared Nov 14, 1989
SONOCA ULTRASONIC SURGICAL SYSTEM
K893926 · LFL
Holl Meditronics, Inc.
General & Plastic Surgery · 167d
Cleared Nov 14, 1989
SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY
K894471 · GEX
Surgilase, Inc.
General & Plastic Surgery · 119d
Cleared Nov 14, 1989
ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.
K894711 · GTZ
Gen-Probe, Inc.
Microbiology · 111d
Cleared Nov 14, 1989
ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION
K894712 · LQO
Gen-Probe, Inc.
Microbiology · 111d
Cleared Nov 14, 1989
HEMOSTASIS VALVE
K895214 · DYB
Applied Vascular Devices, Inc.
Cardiovascular · 88d
Cleared Nov 14, 1989
SELDINGER SINGLE WALL
K895454 · DRC
Advance Medical Designs, Inc.
Cardiovascular · 70d
Cleared Nov 14, 1989
SELDINGER PERCUTANEOUS 2 PC NEEDLES
K895455 · DRC
Advance Medical Designs, Inc.
Cardiovascular · 70d
Cleared Nov 14, 1989
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
K895583 · LSL
Gen-Probe, Inc.
Microbiology · 60d
Cleared Nov 14, 1989
TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
K895664 · CEM
Technicon Instruments Corp.
Chemistry · 55d
Cleared Nov 14, 1989
BREVET DISPOSABLE CONNECTORS
K895753 · DQY
Brevet, Inc.
Cardiovascular · 49d
Cleared Nov 14, 1989
QUANTIMETRIX BILIRUBIN CALIBRATORS
K895778 · JIS
Quantimetrix Medical Industries
Chemistry · 48d
Cleared Nov 14, 1989
TOTAL BILIRUBIN L.F.
K895822 · CIG
Sclavo, Inc.
Chemistry · 46d
Cleared Nov 14, 1989
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600
K896028 · CFR
American Research Products Co.
Chemistry · 29d
Cleared Nov 13, 1989
TDX(R) LITES(TM) LITHIUM
K894328 · JIH
Abbott Laboratories
Chemistry · 122d
Cleared Nov 13, 1989
.22 & 1.2 MICRON IV FILTERS
K894954 · FPB
Churchill Medical Systems, Inc.
General Hospital · 101d