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
139513–139536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1987
DENTAL FACE MASKS, POLYESTER
K871558 · FXX
Carl Parker Associates, Inc.
General Hospital · 91d
Cleared Jul 22, 1987
EASY EYES TM LENS CARRYING CASE
K871741 · LRX
Eaton Medical Corp.
Ophthalmic · 78d
Cleared Jul 22, 1987
TOTAL BILIRUBIN STANDARD CALIBRATOR
K872263 · JIT
Wako Chemicals USA, Inc.
Chemistry · 40d
Cleared Jul 22, 1987
ALTERNATE SUPPLIERS FOR TENS ELECTRODE
K872492 · GXY
Franklin Sales & Mfg. Co.
Neurology · 29d
Cleared Jul 21, 1987
SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282
K861374 · DXN
Kontron Instruments, Inc.
Cardiovascular · 466d
Cleared Jul 21, 1987
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.
K870916 · JOP
Ge Medical Systems Information...
Cardiovascular · 137d
Cleared Jul 21, 1987
KANGLE CONDOM
K871020 · HIS
Lindley Company, Inc.
Obstetrics & Gynecology · 127d
Cleared Jul 21, 1987
HILARIS-NORI ENDOMETRIAL APPLICATOR
K871216 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 117d
Cleared Jul 21, 1987
MODIFIED NOFLO I
K871262 · CCN
Design Technologies, Inc.
Anesthesiology · 112d
Cleared Jul 21, 1987
SERVO VENTILATOR 900 C/D
K871354 · CBK
Siemens Elema AB
Anesthesiology · 106d
Cleared Jul 21, 1987
SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
K871511 · LLO
Medical Energy, Inc.
Anesthesiology · 92d
Cleared Jul 21, 1987
MOSS(R) GASTROSTOMY TUBE CAT #5-17719
K871554 · KNT
Mfg. and Research, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 21, 1987
MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM
K871585 · JWH
Depuy, Inc.
Orthopedic · 89d
Cleared Jul 21, 1987
MEDTENS(TM), MODEL NUMBER 7725
K871722 · GZJ
Medtronic Vascular
Neurology · 78d
Cleared Jul 21, 1987
FILM AND PAPER COMBINATION STERILIZING BAG
K871798 · FRG
Cost Rite Health Products, Inc.
General Hospital · 75d
Cleared Jul 21, 1987
TWO FLUID W/CHECK VALVE
K871843 · FPA
Panamedix, Inc.
General Hospital · 70d
Cleared Jul 21, 1987
HSC UNIT ROD
K871870 · KWP
Research Development Corp.
Orthopedic · 69d
Cleared Jul 21, 1987
IMPERVA-P
K871898 · EBF
Shofu Dental Corp.
Dental · 67d
Cleared Jul 21, 1987
IMPERVA-A
K871899 · EBF
Shofu Dental Corp.
Dental · 67d
Cleared Jul 21, 1987
STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
K871972 · DGE
American Dade
Immunology · 61d
Cleared Jul 21, 1987
EYE GARD
K872000 · HOY
Treace Medical, Inc.
Ophthalmic · 56d
Cleared Jul 21, 1987
BI-ARTICULAR II HIP DEVICE
K872019 · KWY
Zimmer, Inc.
Orthopedic · 56d
Cleared Jul 21, 1987
WASHING/INJECTION NEEDLE
K872060 · FBK
Endovations
Gastroenterology & Urology · 54d
Cleared Jul 21, 1987
INNOFLUOR PHENYTOIN CALIBRATOR SET
K872142 · DLJ
Innotron of Oregon, Inc.
Chemistry · 48d