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
84121–84144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1999
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
K992169 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 122d
Cleared Oct 28, 1999
CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS...
K993245 · DYG
Alba Critical Care, Ltd.
Cardiovascular · 30d
Cleared Oct 28, 1999
PROWLER PLUS INFUSION CATHETER
K993266 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 28d
Cleared Oct 28, 1999
K-ASSAY APO B
K993354 · DER
Kamiya Biomedical Co.
Chemistry · 23d
Cleared Oct 27, 1999
CRICOTHYROTOMY TUBE
K983000 · BTO
Polamedco, Inc.
Anesthesiology · 426d
Cleared Oct 27, 1999
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
K983613 · LYZ
Shanghai Jiatai Plastic Products Co.,...
General Hospital · 378d
Cleared Oct 27, 1999
OXYCONALPHA WITH OPTION ECG
K984465 · LOS
Erich Jaeger B.V.
Cardiovascular · 315d
Cleared Oct 27, 1999
ST-302 INFRAREX
K990233 · ILY
Skylark Device Co., Ltd.
Physical Medicine · 275d
Cleared Oct 27, 1999
ELECTRIC MOBILITY CAVALIER SCOOTERS
K991281 · INI
Electric Mobility Corp.
Physical Medicine · 196d
Cleared Oct 27, 1999
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K992070 · MQG
Cook Urological, Inc.
Obstetrics & Gynecology · 131d
Cleared Oct 27, 1999
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
K992156 · LYZ
Ansell Perry
General Hospital · 124d
Cleared Oct 27, 1999
IV ADMINISTRATION SET
K992266 · FPA
New Alliance of Independent Medical...
General Hospital · 113d
Cleared Oct 27, 1999
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
K992421 · BSZ
Accutron, Inc.
Anesthesiology · 98d
Cleared Oct 27, 1999
TUBULAR ELECTRODE DEVICE
K992542 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 89d
Cleared Oct 27, 1999
ALPHA INFUSION PUMP
K992551 · MEB
Advanced Infusion, Inc.
General Hospital · 89d
Cleared Oct 27, 1999
TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201,...
K992601 · FLL
Oriental System Technology, Inc.
General Hospital · 85d
Cleared Oct 27, 1999
SDB CERCLAGE SYSTEM
K992616 · JDQ
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Oct 27, 1999
HEX BUTTON
K992617 · HTN
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Oct 27, 1999
MODEL IRC 1001 AEROSOL COMPRESSOR
K992643 · CAF
Invacare Corp.
Anesthesiology · 82d
Cleared Oct 27, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K992653 · FIE
Diasol, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 27, 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667 · LPH
Zimmer, Inc.
Orthopedic · 79d
Cleared Oct 27, 1999
NEXT GENERATION RODDING SYSTEM
K992784 · KWQ
United States Surgical, A Division of...
Orthopedic · 69d
Cleared Oct 27, 1999
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER...
K992830 · LZA
Safeskin Corp.
General Hospital · 65d
Cleared Oct 27, 1999
BARIATRIC LAPAROSCOPE, MODEL 367
K993045 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 47d