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
147793–147816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 1985
CHLAMYDIA
K843654 · GPW
Institute Virion , Ltd.
Microbiology · 325d
Cleared Aug 08, 1985
Q-FEVER
K843672 · GPS
Institute Virion , Ltd.
Microbiology · 325d
Cleared Aug 08, 1985
PFEIFFER PUMP
K851525 · CCQ
Ing. Erich Pfeiffer GmbH & Co. Kg.
Anesthesiology · 114d
Cleared Aug 08, 1985
OR TUBE RESTRAINT
K851874 · CBH
Kinetic Concepts, Inc.
Anesthesiology · 101d
Cleared Aug 08, 1985
AMSCO URO-ENDO MOBILE TABLE
K852127 · KQS
American Sterilizer Co.
Gastroenterology & Urology · 85d
Cleared Aug 08, 1985
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET
K852287 · KOB
Cook Ob/Gyn
Gastroenterology & Urology · 71d
Cleared Aug 08, 1985
UNI-PLATE
K852643
Medical Specialties Laboratories
Hematology · 48d
Cleared Aug 08, 1985
SUNGLASSES
K852773 · HQY
Pony Industries Co., Ltd.
Ophthalmic · 44d
Cleared Aug 08, 1985
CORPAK ENTERAL SOL ADM PUMP SET W/ SCREW
K852792 · KNT
Corpak Co.
Gastroenterology & Urology · 38d
Cleared Aug 08, 1985
SUNNY SUN MAGNIFYING GLASSES
K852830 · HQY
Sunny Optical Co., Ltd.
Ophthalmic · 37d
Cleared Aug 08, 1985
ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L
K852834
Ortho Diagnostic Systems, Inc.
Hematology · 37d
Cleared Aug 08, 1985
PRECISION - COSMET CAPSULE COUPEUR
K852934 · HNY
Precision-Cosmet Co., Inc.
Ophthalmic · 30d
Cleared Aug 08, 1985
MAYFIELD DISPOSABLE SKULL PINS
K853066 · HAX
Codman & Shurtleff, Inc.
Neurology · 20d
Cleared Aug 07, 1985
SHARPLAN 1040 CO/2 SURGICAL LASER
K850628 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 169d
Cleared Aug 07, 1985
SHARPLAN MODEL 1060 CO/2 SURGICAL LASER
K850633 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 169d
Cleared Aug 07, 1985
UROBEI STRESS INCONTINENCE MONITOR
K851483 · FAP
Browne Medical, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 07, 1985
DONWAY LIFTING FRAME
K851660 · FPP
Australian Biomedical Corporation , Ltd.
General Hospital · 106d
Cleared Aug 07, 1985
GENESYS GAMMA COUNTER
K851689 · JJJ
Laboratory Technologies, Inc.
Toxicology · 103d
Cleared Aug 07, 1985
THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE
K851813 · KPQ
Victoreen, Inc.
Radiology · 103d
Cleared Aug 07, 1985
EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
K852014 · KOA
Effner and Spreine Co.
Gastroenterology & Urology · 90d
Cleared Aug 07, 1985
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
K852085 · KNX
The Kendal Co.
Gastroenterology & Urology · 86d
Cleared Aug 07, 1985
SIMPLASTIC SUPRA PUBIC CATHETER
K852200 · KOB
Franklin Medical USA, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 07, 1985
ESTEEM INCONTINENT SYSTEM
K852276 · EYQ
Bevan Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Aug 07, 1985
DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM
K852353 · IXI
Thomson-Cgr Medical Corp.
Radiology · 65d