FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81145–81168 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2000
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · DTN
Terumo Cardiovascular Systems Corp.
Cardiovascular · 29d
Cleared Aug 22, 2000
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
K002340 · LYZ
Glormed Intl., Inc.
General Hospital · 21d
Cleared Aug 21, 2000
GLYCOSAL HBA1C TEST
K001392 · LCP
Provalis Diagnostics , Ltd.
Hematology · 110d
Cleared Aug 21, 2000
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL...
K001411 · CEW
Scantibodies Laboratory, Inc.
Chemistry · 109d
Cleared Aug 21, 2000
CARESIDE HEMOGLOBIN
K001462 · KHG
Careside, Inc.
Hematology · 103d
Cleared Aug 21, 2000
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
K001556 · DHN
The Binding Site, Ltd.
Immunology · 95d
Cleared Aug 21, 2000
SYSMEX R-500
K001683 · GKL
Sysmex Corporation of America
Hematology · 81d
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