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
64561–64584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2005
BRC SOFTWARE PRODUCT
K050192 · OLU
Brc Operations Pty Limited
Neurology · 266d
Cleared Oct 20, 2005
AURA-PSG
K050425 · OLV
Astro-Med, Inc.
Neurology · 244d
Cleared Oct 20, 2005
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
K051056 · FRC
Albert Browne , Ltd.
General Hospital · 177d
Cleared Oct 20, 2005
NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE...
K051562 · KGO
Terang Nusa Sdn Bhd
General Hospital · 129d
Cleared Oct 20, 2005
ALARIS SYSTEM PC UNIT, MODEL 8001
K051641 · FRN
Cardinal Health, Alaris Products
General Hospital · 122d
Cleared Oct 20, 2005
POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE
K051991 · LJS
C.R. Bard, Inc.
General Hospital · 90d
Cleared Oct 20, 2005
POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM
K051992 · FMI
Vidacare Corporation
General Hospital · 90d
Cleared Oct 20, 2005
M-SERIES PRO CPAP SYTEM
K052110 · BZD
Respironics, Inc.
Anesthesiology · 77d
Cleared Oct 20, 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 73d
Cleared Oct 20, 2005
AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
K052203 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 69d
Cleared Oct 20, 2005
SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL
K052409 · ELW
Sultan Chemists, Inc.
Dental · 49d
Cleared Oct 20, 2005
G-COAT
K052462 · EBD
GC America, Inc.
Dental · 42d
Cleared Oct 20, 2005
LUNAR IDXA
K052581 · KGI
Ge Medical Systems Ultrasound and...
Radiology · 30d
Cleared Oct 20, 2005
MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
K052648 · NHA
Implant Innovations, Inc.
Dental · 24d
Cleared Oct 20, 2005
M3046B COMPACT PORTABLE PATIENT MONITORS
K052707 · MHX
Philips Medical Systems
Cardiovascular · 21d
Cleared Oct 20, 2005
D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
K052717 · DTM
Dideco S.R.L.
Cardiovascular · 21d
Cleared Oct 20, 2005
MEDLINE IODOFORM PACKING STRIPS
K052720 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 21d
Cleared Oct 20, 2005
THERMAGE THERMACOOL SKIN MARKETING
K052778 · GEI
Thermage, Inc.
General & Plastic Surgery · 17d
Cleared Oct 19, 2005
ZIRACE
K051501 · NHA
Acucera, Inc.
Dental · 135d
Cleared Oct 19, 2005
BLOOD PRESSURE METER, MODEL CH-432
K052046 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 82d
Cleared Oct 19, 2005
EXEL SECURE TOUCH II SAFETY SYRINGE
K052103 · MEG
Exelint Intl. Co.
General Hospital · 77d
Cleared Oct 19, 2005
VITAGEL SURGICAL HEMOSTAT SPRAY SET
K052173 · FMF
Orthovita, Inc.
General Hospital · 70d
Cleared Oct 19, 2005
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002
K052240 · QYX
Cardionet, Inc.
Cardiovascular · 63d
Cleared Oct 19, 2005
CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159,...
K052514 · PDU
Spectranetics Corp.
Cardiovascular · 35d