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

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175,820 results
140425–140448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1987
BACTO(R) STREP GROUP KIT
K870854 · GTZ
Difco Laboratories, Inc.
Microbiology · 56d
Cleared Apr 28, 1987
CRYOSURGICAL PROBE
K871314 · GEH
Western Medical Research
General & Plastic Surgery · 27d
Cleared Apr 28, 1987
VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.
K871331 · DHB
Ventrex Laboratories, Inc.
Immunology · 25d
Cleared Apr 28, 1987
CB-7 ELECTRONIC EPILATOR
K871372 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 21d
Cleared Apr 27, 1987
'EXMOOR' DAS GUPTA LARYNGEAL KEEL
K864936 · FWN
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 132d
Cleared Apr 27, 1987
CENTRAL VENOUS CATHETER
K870075 · DQY
Bd Becton Dickinson Vacutainer...
Cardiovascular · 109d
Cleared Apr 27, 1987
#014160-TAB TUBING ROTATOR ADAPTOR
K870325 · DTL
Clinical Connections, Inc.
Cardiovascular · 89d
Cleared Apr 27, 1987
VASCATH VASCULAR CATHETER PLACEMENT KIT
K870542 · DYB
Titan Medical, Inc.
Cardiovascular · 77d
Cleared Apr 27, 1987
BPA CARDIOVASCULAR PRESSURE AMPLIFIER
K870783 · DRQ
Fisher Imaging Corp.
Cardiovascular · 60d
Cleared Apr 27, 1987
PACEMAKER FUNCTION ANALYZER
K870909 · KRE
Paceart, Inc.
Cardiovascular · 53d
Cleared Apr 27, 1987
SCHIRMER NYLON SUTURE LASER LENS
K871099 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 39d
Cleared Apr 27, 1987
INTRA-ARTICULATED ARTHRO POWER SYSTEM
K871250 · KIT
Richard Wolf Medical Instruments Corp.
Pathology · 28d
Cleared Apr 27, 1987
KNIFE, OPHTHALMIC
K871285 · HNN
Trueline Instruments, Inc.
Ophthalmic · 27d
Cleared Apr 27, 1987
SDI TOTAL HIP SYSTEM
K871299 · JDI
Orthomet, Inc.
Orthopedic · 27d
Cleared Apr 27, 1987
DROP MATE
K871326
Mtr Enterprises, Ltd.
Ophthalmic · 24d
Cleared Apr 27, 1987
BLOOD VESSEL CONNECTOR
K871408
Quali-Med, Inc.
Cardiovascular · 19d
Cleared Apr 24, 1987
SURE DROP
K870905
Sheldon Eyedrop Support, Inc.
Ophthalmic · 50d
Cleared Apr 23, 1987
BIOJECTOR SYRINGE SYSTEM
K861687 · KZE
Bioject, Inc.
General Hospital · 356d
Cleared Apr 23, 1987
CARERITE & COST RITE NYLON STERILIZATION FILM
K870147 · FRG
Cost Rite Health Products, Inc.
General Hospital · 100d
Cleared Apr 23, 1987
MODEL MICRO ST AMBULATORY ECG MONITOR
K870537 · DSH
Advanced Medical Products, Inc.
Cardiovascular · 73d
Cleared Apr 23, 1987
MODEL 192 PRINTER
K870538 · DSF
Advanced Medical Products, Inc.
Cardiovascular · 73d
Cleared Apr 23, 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET
K870581 · FPA
Strato Medical Corp.
General Hospital · 71d
Cleared Apr 23, 1987
LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE
K870582 · FPA
Strato Medical Corp.
General Hospital · 71d
Cleared Apr 23, 1987
TIMLEINE(TM) VENIPUNCTURE SYSTEM
K870770 · KMK
Ipax, Inc.
General Hospital · 56d