FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123577–123600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1991
ULTRA WAVE 101
K905836 · IRO
Ako USA, Inc.
Physical Medicine · 14d
Cleared Jan 14, 1991
ACME MODEL 8500 WHEELCHAIR SCALE
K910055 · INF
Acme Medical Scale Co.
Physical Medicine · 7d
Cleared Jan 11, 1991
MODULAR UNIPOLAR SYSTEM
K902365 · KWL
Howmedica Corp.
Orthopedic · 226d
Cleared Jan 11, 1991
SRI JOHANI LATEX SURGEONS GLOVES
K904662 · KGO
Transcorp
General Hospital · 88d
Cleared Jan 11, 1991
MODEL IW17.5A INTRA OPERATIVE TRANSDUCER
K904665 · ITX
Kretztechnik AG
Radiology · 88d
Cleared Jan 11, 1991
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR
K904806 · KDJ
Fresenius USA, Inc.
Gastroenterology & Urology · 79d
Cleared Jan 11, 1991
VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS
K904886 · FPA
Florida Infusion Services, Inc.
General Hospital · 77d
Cleared Jan 11, 1991
TRACH COLLAR
K904974 · CBH
Rotek Corp.
Anesthesiology · 80d
Cleared Jan 11, 1991
ABUSCREEN ONLINE TM FOR THC
K904996 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Jan 11, 1991
MODEL 3100-21: QUADRATURE SPINE COIL
K905095 · LNH
Medical Advances, Inc.
Radiology · 59d
Cleared Jan 11, 1991
IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER
K905215 · JJQ
Cirrus Diagnostics, Inc.
Chemistry · 52d
Cleared Jan 11, 1991
MOOR LASER BLOOD FLOW MONITOR MBF3
K905232 · GEX
Moor Instruments, Ltd.
General & Plastic Surgery · 52d
Cleared Jan 11, 1991
MOOR LASER BLOOD FLOW MONITOR MBF3D
K905233 · GEX
Moor Instruments, Ltd.
General & Plastic Surgery · 52d
Cleared Jan 11, 1991
PERRY XTENDA CUFF SURGICAL GLOVES
K905537 · KGO
Smith & Nephew Perry
General Hospital · 31d
Cleared Jan 11, 1991
MODIFIED WALKMED 400
K905783 · FRN
Medfusion, Inc.
General Hospital · 24d
Cleared Jan 11, 1991
MODEL 556 MONITOR
K905856 · DSF
Ge Medical Systems Information...
Cardiovascular · 88d
Cleared Jan 09, 1991
ICON
K903315 · JWM
Siemens Gammasonics, Inc.
Radiology · 169d
Cleared Jan 09, 1991
CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
K903976 · LZO
Kinamed, Inc.
Orthopedic · 134d
Cleared Jan 08, 1991
DCL SYPHILIS-M CATALOG NO. 600-80
K895964 · LIP
Diagnostic Chemicals, Ltd. (Usa)
Microbiology · 454d
Cleared Jan 08, 1991
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · CBK
Puritan Bennett Corp.
Anesthesiology · 216d
Cleared Jan 08, 1991
OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C
K903134 · DXN
Omron Marshall Products, Inc.
Cardiovascular · 175d
Cleared Jan 08, 1991
ROBERTAZZI NASOPHARYNGEAL AIRWAY
K903618 · BTQ
Eastmed Enterprises, Inc.
Anesthesiology · 154d
Cleared Jan 08, 1991
SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
K903900 · DSK
Ppg Hellige B.V.
Cardiovascular · 138d
Cleared Jan 08, 1991
BIO-IMPEDANCE ANALYZER
K904109 · DSB
Xitron Technologies, Inc.
Cardiovascular · 124d