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
144745–144768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1986
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
K861055 · JJE
Em Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Apr 24, 1986
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K861057 · HNR
Precision-Cosmet Co., Inc.
Ophthalmic · 36d
Cleared Apr 24, 1986
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
K861061 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 24, 1986
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K861141 · HNR
CooperVision, Inc.
Ophthalmic · 29d
Cleared Apr 24, 1986
CLEARBLUE PREGNANCY TESTING KIT
K861168 · LCX
Unipath , Ltd.
Chemistry · 27d
Cleared Apr 24, 1986
ULTROSPEC K KINETICS SPECTROPHOTOMETER
K861194 · JJQ
Lkb Instruments, Inc.
Chemistry · 24d
Cleared Apr 24, 1986
GLUCOSE OXIDASE PROCEDURE
K861204 · CGA
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Apr 24, 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
K861221 · JJX
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Apr 24, 1986
GLUCOSE (HEXOKINASE) REAGENT SET
K861311 · CFR
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Apr 24, 1986
MMS T4 RIA KIT
K861320 · CDX
Micromedic Systems
Chemistry · 16d
Cleared Apr 24, 1986
NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY
K861328 · EAP
Belmont Equipment Corp.
Radiology · 15d
Cleared Apr 24, 1986
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET
K861413 · CIG
Medical Analysis Systems, Inc.
Chemistry · 9d
Cleared Apr 23, 1986
CUDDLE HEART -AUDITORY/VIBRATION DEVICE
K845002 · FMS
International Purchasing Services
General Hospital · 483d
Cleared Apr 23, 1986
CUDDLE CARRIER - INFANT BED
K845003 · FMS
International Purchasing Services
General Hospital · 483d
Cleared Apr 23, 1986
CRIB CUDDLE - INFANT BED
K845004 · FMS
International Purchasing Services
General Hospital · 483d
Cleared Apr 23, 1986
NO FLOSS FLOSSER
K854326 · JEQ
Rgm Assoc.
Dental · 177d
Cleared Apr 23, 1986
HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
K854590 · JAF
Philips Medical Systems, Inc.
Radiology · 156d
Cleared Apr 23, 1986
SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ
K854591 · JAF
Philips Medical Systems, Inc.
Radiology · 156d
Cleared Apr 23, 1986
5000 SERIES ECG ELECTRODES
K854757 · DRX
Alternative Design Systems, Inc.
Cardiovascular · 147d
Cleared Apr 23, 1986
MODIFIED CHERNE CAD DETECTOR
K860015 · DXG
Cherne Industries, Inc.
Cardiovascular · 110d
Cleared Apr 23, 1986
TA-6C - PART NUMBER SLZ 7520
K860262 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 89d
Cleared Apr 23, 1986
MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY
K860273 · GEX
Britt Corp., Inc.
General & Plastic Surgery · 86d
Cleared Apr 23, 1986
URDYN 5000 (UROFLOWMETER)
K860368 · FFO
Dantec Electronics, Inc.
Gastroenterology & Urology · 79d
Cleared Apr 23, 1986
MEADOX SURGIMED GUIDE CATHETER
K860429 · DQO
Meadox Surgimed, Inc.
Cardiovascular · 78d