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
75841–75864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 2002
MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL...
K021305 · DXN
Microlife Corp.
Cardiovascular · 65d
Cleared Jun 28, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM...
K021345 · FGE
Cordis Corp.
Gastroenterology & Urology · 60d
Cleared Jun 28, 2002
APEX MEDICAL DIGITAL EMS TS1311, TS1312
K021754 · IPF
Apex Medical Corp.
Physical Medicine · 30d
Cleared Jun 28, 2002
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
K021943 · CGA
Lifescan, Inc.
Chemistry · 31d
Cleared Jun 27, 2002
ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
K003720 · KPL
Lifestream Purfication Systems, LLC
Gastroenterology & Urology · 570d
Cleared Jun 27, 2002
REPROCESSED ELECTROSURGICAL ELECTRODES
K012669 · GEI
Surgical Instruments Service and...
General & Plastic Surgery · 318d
Cleared Jun 27, 2002
SOFT PLUG ABSORBABLE PLUG-SA
K013613 · LZU
Oasis Medical, Inc.
Ophthalmic · 234d
Cleared Jun 27, 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
K020979 · GKP
Dade Behring, Inc.
Hematology · 93d
Cleared Jun 27, 2002
REX, VERSION 1.0
K021099 · LLZ
Pointdx, Inc.
Radiology · 84d
Cleared Jun 27, 2002
MILLENNIUM 5000 MEUROVASCULAR COIL
K021141 · MOS
Usa Instruments, Inc.
Radiology · 79d
Cleared Jun 27, 2002
ORS-1000LD
K021288 · LHC
O.R. Solutions, Inc.
General Hospital · 65d
Cleared Jun 27, 2002
H12+HOLTER RECORDER
K021373 · MWJ
Mortara Instrument, Inc.
Cardiovascular · 57d
Cleared Jun 27, 2002
EXTENSION SET LIGHT-SAFE, MODEL BC565
K021480 · FPA
Codan US Corp.
General Hospital · 50d
Cleared Jun 27, 2002
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
K021532 · JIT
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 27, 2002
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
K021535 · JIT
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 27, 2002
RDI HS CRP CALIBRATOR SET
K021607 · JIT
Reference Diagnostics, Inc.
Immunology · 42d
Cleared Jun 27, 2002
RDI HS CRP KIT
K021609 · DCK
Reference Diagnostics, Inc.
Chemistry · 42d
Cleared Jun 27, 2002
WELCH ALLYN ABPM 6100
K021756 · DXN
Welch Allyn, Inc.
Cardiovascular · 29d
Cleared Jun 27, 2002
L.E.DEMETRON
K021797 · EBZ
Sybron Dental Specialties, Inc.
Dental · 27d
Cleared Jun 27, 2002
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 24d
Cleared Jun 26, 2002
KAVO QUATTROCARE
K012308 · EFB
Kavo America
Dental · 338d
Cleared Jun 26, 2002
GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX
K014114 · FMF
Nipro Diabetes Systems, Inc.
General Hospital · 194d
Cleared Jun 26, 2002
GARD FILTER, COMBIGARD FILTE / HME
K014281 · CAH
Munktell Filter AB
General Hospital · 181d
Cleared Jun 26, 2002
BACSTOP FILTER,BACSTOP FILTER/HME
K014282 · CAH
Munktell Filter AB
General Hospital · 181d