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
138241–138264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1987
LIGHT-SPOT FIBEROPTIC LASER HANDPIECE
K873664 · GEX
Laserguide
General & Plastic Surgery · 57d
Cleared Nov 06, 1987
BAIR HUGGER(TM) - PATIENT WARMING SYSTEM
K873745 · DWJ
Augustine Medical, Inc.
Cardiovascular · 51d
Cleared Nov 06, 1987
HUMID-VENT(R) MINI
K873767 · BYD
Gibeck Respiration
Anesthesiology · 51d
Cleared Nov 06, 1987
M300 MONITOR/CONTROLLER T500 TREADMILL
K873774 · DXJ
Burdick Corp.
Cardiovascular · 51d
Cleared Nov 06, 1987
PRESSURE BARRIER KIT CAT. NO. PBK-3
K873802 · DXS
American Omni Medical, Inc.
Cardiovascular · 49d
Cleared Nov 06, 1987
SARNS WARMER, PART #164975 AND #164980
K873813 · DWC
3M Health Care, Sarns
Cardiovascular · 49d
Cleared Nov 06, 1987
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
K873923 · DTZ
American Bentley
Cardiovascular · 42d
Cleared Nov 06, 1987
LEVTECH CLAMP APPLIER
K874023 · HTD
Levtech, Inc.
General & Plastic Surgery · 35d
Cleared Nov 06, 1987
MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY
K874036 · CCK
Novametrix Medical Systems, Inc.
Anesthesiology · 32d
Cleared Nov 06, 1987
EASY-TEST CREATININE (CREA) ITEM NO. 19009
K874088 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Nov 06, 1987
MODEL 410 DENTAL X-RAY FILM PROCESSORS
K874118 · EGY
Dent-X Co.
Radiology · 28d
Cleared Nov 06, 1987
AESTHESIOMETER
K874300 · GWI
Orthopedic Systems, Inc.
Neurology · 17d
Cleared Nov 06, 1987
STAPHYLASE TEST
K874303 · LHT
Oxoid U.S.A., Inc.
Microbiology · 17d
Cleared Nov 06, 1987
QUAD PLATE (4 DIFFERENT MEDIA)
K874344 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Nov 06, 1987
TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050
K874345 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 17d
Cleared Nov 06, 1987
HR(TM) NEEDLE AND SYRINGE
K874372 · FMI
Icu Medical, Inc.
General Hospital · 11d
Cleared Nov 06, 1987
HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
K874404 · FLL
Mallinckrodt Critical Care
General Hospital · 9d
Cleared Nov 06, 1987
IV-PUSH, CONSTANT INFUSION PUMP
K874454 · KZD
Medical Products Search, Inc.
General Hospital · 9d
Cleared Nov 05, 1987
SKINLESS SKIN-HARMONY CONDOMS
K872664 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 120d
Cleared Nov 05, 1987
SKINLESS-SKIN, PINK TINT (CONDOM)
K872812 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 112d
Cleared Nov 05, 1987
FLEXIFLO COMPANION ENTERAL NUTRITION PUMP
K873119 · LZH
Frantz Medical Development, Ltd.
General Hospital · 87d
Cleared Nov 05, 1987
VALLEYLAB MODEL IV7200 INFUSION PUMP
K873161 · FRN
Valleylab, Inc.
General Hospital · 86d
Cleared Nov 05, 1987
WAKO(TM) AUTOKIT CK-NAC
K873201 · CGS
Wako Chemicals USA, Inc.
Chemistry · 84d
Cleared Nov 05, 1987
DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220
K873311 · KMK
Dale Medical Products, Inc.
General Hospital · 80d