Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
147937–147960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1985
PRIME AIRE O2 PLUS 2
K851437 · CAW
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
MOBILAIRE II(P2A) OXYGEN CONCENTRATOR
K851438 · CAW
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
MOBILAIRE, PLA-01 OXYGEN CONCENTRATOR
K851439 · CAW
Invacare Corp.
Anesthesiology · 110d
Cleared Jul 29, 1985
COLOR OVULATION TEST
K851445 · CEP
Nms Pharmaceuticals, Inc.
Chemistry · 109d
Cleared Jul 29, 1985
3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA
K851616 · JOP
Ausonics Pty , Ltd.
Cardiovascular · 102d
Cleared Jul 29, 1985
MORTARA INSTRUMENT MODEL EL-1
K851702 · DSI
Mortara Instrument, Inc.
Cardiovascular · 96d
Cleared Jul 29, 1985
SOEHENDRA BILIARY DILATING CATHETER-SBDC-7
K851960 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 29, 1985
WILSON-COOK STONE EXTRACTOR
K851965 · FFL
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 29, 1985
DENTIN ADHESIVE
K852024
Dentsply Intl.
Dental · 82d
Cleared Jul 29, 1985
QUIDEL QUEST OVULATION TEST
K852146 · CEP
Quidel Corp.
Chemistry · 74d
Cleared Jul 29, 1985
329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR
K852253 · DTD
Cordis Corp.
Cardiovascular · 66d
Cleared Jul 29, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Jul 29, 1985
EXTRA LARGE ADHESIVE STRIPS
K852408 · KGX
American White Cross, Inc.
General & Plastic Surgery · 53d
Cleared Jul 29, 1985
NON-ADHERENT PAD
K852412 · EFQ
American White Cross, Inc.
General & Plastic Surgery · 53d
Cleared Jul 29, 1985
BLOOD TUBING SET
K852605 · FJK
Medflex International, Inc.
Gastroenterology & Urology · 40d
Cleared Jul 29, 1985
CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353
K852678 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 34d
Cleared Jul 29, 1985
FIBERLASE 100 MEDICAL LASER SYSTEM
K852798 · LNK
Laser Media
Gastroenterology & Urology · 28d
Cleared Jul 29, 1985
STERILE DISPOSABLE SYRINGES(2 PIECES)
K852818 · FMF
Fabersanitas, S.A.
General Hospital · 28d
Cleared Jul 29, 1985
DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT)
K852821 · BZD
Puritan Bennett Corp.
Anesthesiology · 27d
Cleared Jul 29, 1985
SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281
K852915 · DTB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284
K852916 · DYB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283
K852917 · DYB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
SLIM ART J. BIP PACING LEAD USING POLY #030-2821
K852918 · DYB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
HUCK TOWEL
K852945 · KKX
South Mountain Medical
General Hospital · 18d