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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
82273–82296 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2000
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K001875 · LFX
Diamedix Corp.
Microbiology · 62d
Cleared Aug 21, 2000
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
K001981 · MID
Axis-Shield , Ltd.
Immunology · 53d
Cleared Aug 21, 2000
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
K002120 · JJS
Bio-Rad
Chemistry · 39d
Cleared Aug 18, 2000
DOSE 1
K000209 · IYE
Scanditronix Wellhofer North America
Radiology · 207d
Cleared Aug 18, 2000
FLO ASSISTANT, MODEL 4-250-00
K001325 · LJH
Northgate Technologies, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 18, 2000
CANDELA DYNAMIC COOLING DEVICE
K001589 · GEX
Candela Corp.
General & Plastic Surgery · 87d
Cleared Aug 18, 2000
HUNTER SCIENTIFIC INJECTION PIPETTES
K001615 · MQH
Hunter Scientific Limited
Obstetrics & Gynecology · 85d
Cleared Aug 18, 2000
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
K001653 · KWP
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Aug 18, 2000
ORTHONE
K001773 · LNH
Oni, Inc.
Radiology · 67d
Cleared Aug 18, 2000
PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325
K001827 · FPA
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
PARADIGM 1.5ML RESERVOIR, MODEL 326
K001828 · FRN
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
MINIMED PARADIGM INSULIN PUMP, MODEL 511
K001829 · FRN
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318
K001832 · FPA
Minimed, Inc.
General Hospital · 63d
Cleared Aug 18, 2000
KONTUR 55 SOFT LENS
K001908 · LPL
Kontur Kontact Lens Co., Inc.
Ophthalmic · 57d
Cleared Aug 18, 2000
TREATVISION
K002194 · LHN
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Aug 18, 2000
GE MARQUETTE ECG ANALYSIS PROGRAM
K002209 · MHX
General Electric Medical Systems...
Cardiovascular · 28d
Cleared Aug 18, 2000
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · DRX
Cambridge Heart, Inc.
Cardiovascular · 25d
Cleared Aug 18, 2000
ML EYE SPEAR, MODEL ML 27 ES
K002279 · HOZ
Med-Logics, Inc.
Ophthalmic · 23d
Cleared Aug 18, 2000
POWERDRIVE 350 OPTION
K002415 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 10d
Cleared Aug 18, 2000
REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT
K993389 · HIS
Remed Pharma
Obstetrics & Gynecology · 315d
Cleared Aug 18, 2000
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT
K993403 · HIS
Remed Pharma
Obstetrics & Gynecology · 315d
Cleared Aug 18, 2000
REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT
K993409 · HIS
Remed Pharma
Obstetrics & Gynecology · 315d
Cleared Aug 17, 2000
STACKHOUSE LENS HOOD, MODEL SA-700/F
K000605 · FYA
Stackhouse, Inc.
General Hospital · 176d
Cleared Aug 17, 2000
GROSS FEMORAL COMPONENT
K001580 · MEH
Biomet, Inc.
Orthopedic · 87d