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
145969–145992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1986
CARE IV BURN PAD, CATALOG #'S BP2334,BP3472
K855160
Howard Associates, Inc.
General & Plastic Surgery · 29d
Cleared Jan 24, 1986
CEFACLOR 30 MCG SENSITIVITY DISCS
K855206 · JTN
Difco Laboratories, Inc.
Microbiology · 25d
Cleared Jan 24, 1986
MINOR SURGERY LIGHT MODEL 2112
K860020 · FSS
Adel Medical , Ltd.
General & Plastic Surgery · 21d
Cleared Jan 24, 1986
STREP D FLUOR
K860041 · GTP
Bio Spec, Inc.
Microbiology · 18d
Cleared Jan 24, 1986
OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM
K860080 · JJE
Olympus Corp.
Chemistry · 16d
Cleared Jan 24, 1986
PL EXAM LIGHT
K860088 · FTD
Burton Medical Products Corp.
General & Plastic Surgery · 14d
Cleared Jan 24, 1986
DIGIKIT NONPNEUMATIC TOURNIQUET
K860095 · KCY
Orthofab, Inc.
General & Plastic Surgery · 14d
Cleared Jan 24, 1986
TOTAL LIPIDS REAGENT SET
K860112 · CFD
Technostics Intl.
Chemistry · 11d
Cleared Jan 23, 1986
TERUMO SURFLO ETFE I.V. CATHETER
K854566 · FOZ
Terumo Medical Corp.
General Hospital · 79d
Cleared Jan 23, 1986
IVAC CONTROLLED RELEASE INFUSION SYSTEM
K854574 · FPA
Y
General Hospital · 79d
Cleared Jan 23, 1986
ENTERAL FEEDING BAG
K854616 · KNT
Medovations, Inc.
Gastroenterology & Urology · 66d
Cleared Jan 23, 1986
MANTA DENTAL CHAIR
K854644 · KLC
Alpine Dental Equipment Co.
Dental · 65d
Cleared Jan 23, 1986
NEOCUSSOR (MASSAGER, BATTERY) POWERED
K855129 · BYI
General Physiotherapy, Inc.
Anesthesiology · 31d
Cleared Jan 23, 1986
DYNAFEED ENTERAL PUMP FEED BAG
K860075 · KNT
Medline Industries, Inc.
Gastroenterology & Urology · 16d
Cleared Jan 22, 1986
MODEL TRC-40 TELEMETRY RECIEVER MODULE
K851623 · DXH
Eaton Medical Group
Cardiovascular · 279d
Cleared Jan 22, 1986
INTRA-AORTIC BALLOON PUMP MODEL K2000
K853062 · DSP
Kontron Instruments, Inc.
Cardiovascular · 187d
Cleared Jan 22, 1986
CMS 8000
K853096 · DXH
Physio-Control Corp.
Cardiovascular · 183d
Cleared Jan 22, 1986
NARKOMED 3 ANESTHESIA SYSTEM
K853435 · BSZ
Draeger Medical, Inc.
Anesthesiology · 160d
Cleared Jan 22, 1986
IOSERT LENS IMPLANT INSTRUMENT
K854197 · KYB
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Jan 22, 1986
SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
K854245 · KQN
Sigma Diagnostics, Inc.
Chemistry · 93d
Cleared Jan 22, 1986
DSL ANDROSTENEDIONE RIA (DSL # 4200)
K854673 · CIZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 62d
Cleared Jan 22, 1986
TRIGLYCERIDE'S TEST (TRIGLI-CINET)
K854783 · CDT
Sclavo, Inc.
Chemistry · 54d
Cleared Jan 22, 1986
V-TREND DIG ENZYME IMMUNOASSAY TEST KIT
K854972 · KXT
V-Tech, Inc.
Chemistry · 42d
Cleared Jan 22, 1986
SERALYZER TOTAL BILIRUBIN CALIBRATORS
K855040 · JIS
Miles Laboratories, Inc.
Chemistry · 36d