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
144097–144120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1986
WAXTREAT F
K861801
Beaute Naturelle International, Inc.
General & Plastic Surgery · 39d
Cleared Jun 17, 1986
MULTI-4 CO-OXIMETER CONTROL
K861901 · JJY
Allied Instrumentation Laboratory
Chemistry · 32d
Cleared Jun 17, 1986
CHILDREN'S SUNGLASSES
K861927 · HQY
Jestroy, Ltd.
Ophthalmic · 29d
Cleared Jun 17, 1986
SOFT LENS FOLDER
K861990 · KYB
Staar Surgical Co.
Ophthalmic · 25d
Cleared Jun 17, 1986
ZEISS 30 SL-L
K862004 · HJO
Carl Zeiss, Inc.
Ophthalmic · 21d
Cleared Jun 17, 1986
SPIROMATE AS-600
K862023 · BZG
Riko Medical & Scientific Instrument...
Anesthesiology · 20d
Cleared Jun 17, 1986
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
K862037 · DXY
Medtronic Vascular
Cardiovascular · 20d
Cleared Jun 17, 1986
MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER
K862038 · DXY
Medtronic Vascular
Cardiovascular · 20d
Cleared Jun 17, 1986
WM10, WM20, WM30 POWER MASSAGER
K862041 · ISA
Associated Mills, Inc.
Physical Medicine · 20d
Cleared Jun 17, 1986
INTER-SHARP
K862070 · HNW
Intermedics Intraocular, Inc.
Ophthalmic · 18d
Cleared Jun 17, 1986
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
K862071 · DXY
Medtronic Vascular
Cardiovascular · 18d
Cleared Jun 17, 1986
FACE TANNER
K862097 · FTC
Tan America Mfg.
General & Plastic Surgery · 15d
Cleared Jun 17, 1986
VISION ALBUMIN
K862138 · CJW
Abbott Laboratories
Chemistry · 13d
Cleared Jun 17, 1986
SUN-DREAMER SUNTANNING BED
K862142 · FTC
Sun-Dream Tanning , Ltd.
General & Plastic Surgery · 13d
Cleared Jun 17, 1986
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
K862207 · LCX
Quidel Corp.
Chemistry · 7d
Cleared Jun 17, 1986
MICRO THIN* PARAFFIN
K862223 · KEO
Richard-Allan Medical Ind., Inc.
Pathology · 6d
Cleared Jun 16, 1986
DIRECT
K852960 · CGA
University of Wisconsin
Chemistry · 339d
Cleared Jun 16, 1986
ERG 550 ERGOMETER BICYCLE
K854491 · DRT
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 551 ERGOMETER, BICYCLE
K854492 · DRT
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 555 COUCH ERGOMETER
K854493 · DRT
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
PHYSIO-DYNE ECG/HR 3
K854847 · DRT
Physio-Dyne Industrument Corp.
Cardiovascular · 194d
Cleared Jun 16, 1986
LINEAR SCANNER PROBE, MODEL TL-50
K854959 · IYO
Elscint, Inc.
Radiology · 187d
Cleared Jun 16, 1986
ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS
K860081 · IYO
Elscint, Inc.
Radiology · 159d
Cleared Jun 16, 1986
STORZ, ALPHA II BIOMETRIC RULER
K860553 · ITX
Storz Instrument Co.
Radiology · 122d