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
150361–150384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1985
BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE
K844730 · FRN
C.R. Bard, Inc.
General Hospital · 55d
Cleared Jan 28, 1985
FLOW MED SK 140 BURET
K844820 · FPA
D.R.O. Medical, Inc.
General Hospital · 52d
Cleared Jan 28, 1985
SYSTE MATE IRON, HEM NO. 67224
K845020 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Jan 28, 1985
STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000
K845023 · LGX
Storz Instrument Co.
General Hospital · 32d
Cleared Jan 25, 1985
TRANSDUCER 4.OMHZ LA4011
K841048
Philips Ultrasound, Inc.
Radiology · 319d
Cleared Jan 25, 1985
THE BIBICURE SYS BREAST TONER
K843544 · HGY
Les Entreprises Bibi, Inc.
Obstetrics & Gynecology · 140d
Cleared Jan 25, 1985
ELEX ELECTRONIC DIGITAL THERMOMETER
K843609 · FLL
Ewing Intl. , Ltd.
General Hospital · 134d
Cleared Jan 25, 1985
ABBOTT LIFECARE 900 VOLUMETRIC PUMP
K844091 · FRN
Abbott Laboratories
General Hospital · 95d
Cleared Jan 25, 1985
K.M. PRODUCTS ASPIRATOR
K844200 · BTA
Km Products
General & Plastic Surgery · 87d
Cleared Jan 25, 1985
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
K844407 · GTJ
Bd Becton Dickinson Vacutainer...
Microbiology · 73d
Cleared Jan 25, 1985
ABBOTT LIFECARE 500 INFUSER
K844768 · FRN
Abbott Laboratories
General Hospital · 49d
Cleared Jan 25, 1985
HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP
K844879 · FNM
Huntleigh Technology, Inc.
General Hospital · 39d
Cleared Jan 25, 1985
HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
K844880 · FNM
Huntleigh Technology, Inc.
General Hospital · 39d
Cleared Jan 25, 1985
IVAC 52-99-0 UNVENTED & 52-99-1 VENTED VOL. INFUSI
K844937 · FPA
Y
General Hospital · 37d
Cleared Jan 24, 1985
CARDIOVIT CV-3
K841254 · DPS
Schiller AG
Cardiovascular · 304d
Cleared Jan 24, 1985
PDS POLYDIOXANONE MESH
K844228 · FTM
Ethicon, Inc.
General & Plastic Surgery · 84d
Cleared Jan 24, 1985
INTERCEPTOR, 662-01
K844279 · GZJ
Intermedics, Inc.
Neurology · 80d
Cleared Jan 24, 1985
SUNDT-KEES REINFORCING ANEURYSM CLIP
K844352 · HCH
Kees Surgical Specialty Co., Inc.
Neurology · 76d
Cleared Jan 24, 1985
GORE-TEX TUNNELER
K844584 · DWS
W.L. Gore & Associates, Inc.
Cardiovascular · 62d
Cleared Jan 24, 1985
PACE AID MODEL 53
K844811 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 44d
Cleared Jan 24, 1985
OMNIMED NASAL OXYGEN CANNULA
K850066 · CAT
Omni Intl., Inc.
Anesthesiology · 16d
Cleared Jan 24, 1985
AIRCO NITROUS OXIDE REGULATOR
K850106 · CAN
Airco, Inc.
Anesthesiology · 13d
Cleared Jan 24, 1985
AIRES TUOHY NEEDLES 17GA. X 4 1/2
K850111 · BSP
Aries Medical, Inc.
Anesthesiology · 10d
Cleared Jan 23, 1985
MX2 ELECTRONIC STETHOSCOPE
K842705 · DQD
Medmax, Inc.
Cardiovascular · 196d