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
149233–149256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1985
ION 2 REAGENT KI
K851350 · CEM
Hi Chem, Inc.
Chemistry · 25d
Cleared Apr 29, 1985
UNITEK DISPOSABLE IMPRESSION SYRINGE
K851386 · EID
Unitek Corp.
Dental · 20d
Cleared Apr 29, 1985
HOSPAL FISTULA NEEDLE
K851453 · FIE
Hospal Medical Corp.
Gastroenterology & Urology · 18d
Cleared Apr 29, 1985
A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS
K851454 · ECQ
A Company, Inc.
Dental · 18d
Cleared Apr 29, 1985
SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR
K851481 · LED
Difco Laboratories, Inc.
Pathology · 14d
Cleared Apr 29, 1985
TOURNIQUET
K851482 · GAX
Polymer Technology Corp.
General & Plastic Surgery · 14d
Cleared Apr 29, 1985
KINYOUN ACID FAST STAIN KIT
K851493 · JTS
Accra Laboratories, Inc.
Pathology · 14d
Cleared Apr 29, 1985
TWO-STEP ACID FAST BACTERIA STAIN
K851494 · JTS
Accra Laboratories, Inc.
Pathology · 14d
Cleared Apr 29, 1985
MUELLER HINTON SENSITIVITY PLATE
K851518 · JTZ
Culture Kits, Inc.
Immunology · 14d
Cleared Apr 25, 1985
CONCENTRICAL CONTINUOUS PASSIVE MOTION MACHINE
K850030 · BXB
Arc Motion , Ltd.
Physical Medicine · 111d
Cleared Apr 25, 1985
OIL EMULSION NON-ADHERING DRESSING
K850126 · FRO
Absorbent Cotton Co., Inc.
General & Plastic Surgery · 101d
Cleared Apr 25, 1985
DALTON FOLDING WHEELCHAIRS
K850178 · IOR
Dalton Instrument Corp.
Physical Medicine · 98d
Cleared Apr 25, 1985
SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT
K850274 · BXB
Sutter Biomedical, Inc.
Physical Medicine · 92d
Cleared Apr 25, 1985
TELEVISION CONTROL OPTION 1219
K850313 · IQA
Rehab Technology, Inc.
Physical Medicine · 90d
Cleared Apr 25, 1985
TELEVISION CONTROL OPTION 1220
K850314 · IQA
Rehab Technology, Inc.
Physical Medicine · 90d
Cleared Apr 25, 1985
MICRO-STRUC. ACETABULAR COMPON- MC2P
K850352 · JDL
Osteonics Corp.
Orthopedic · 87d
Cleared Apr 25, 1985
CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO
K850374 · CBK
Siemens Elema AB
Anesthesiology · 84d
Cleared Apr 25, 1985
ITI 200 ELECTRIC MOTOR DRIVE, UNIV.-WHEELCHAIR ACC
K850388
Instrument Technology, Inc.
Physical Medicine · 83d
Cleared Apr 25, 1985
CERVICAL COLLARS & HEAD HALTERS
K850465 · IQK
Abco Dealers, Inc.
Physical Medicine · 87d
Cleared Apr 25, 1985
PRESSURE RELIEF ADAPTOR
K850559 · CAX
Precision Medical, Inc.
Anesthesiology · 72d
Cleared Apr 25, 1985
MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR
K850601 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Apr 25, 1985
1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE
K850602 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 69d
Cleared Apr 25, 1985
EXOTHERMIC HEATING PAD
K850637 · IMD
Travenol Laboratories, S.A.
Physical Medicine · 65d
Cleared Apr 25, 1985
CARDIOVIT CS-6 ECG-RECORDER
K850702 · DPS
Schiller AG
Cardiovascular · 63d