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
75145–75168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2002
DIDECO ELECTA
K020647 · CAC
Dideco S.P.A.
Anesthesiology · 189d
Cleared Sep 05, 2002
AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100
K020693 · DWF
Embol-X, Inc.
Cardiovascular · 185d
Cleared Sep 05, 2002
MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1...
K021875 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 90d
Cleared Sep 05, 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891 · LPH
Zimmer, Inc.
Orthopedic · 90d
Cleared Sep 05, 2002
CLASSIC NMS
K021905 · IPF
Care Rehab, Inc.
Physical Medicine · 87d
Cleared Sep 05, 2002
PICCOLO PHOSPHORUS TEST SYSTEM
K022312 · CEO
Abaxis, Inc.
Chemistry · 50d
Cleared Sep 05, 2002
DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E
K022368 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 45d
Cleared Sep 05, 2002
MEDRAD TRANSFER SET
K022431 · FPK
Medrad, Inc.
General Hospital · 42d
Cleared Sep 05, 2002
POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN...
K022442 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 42d
Cleared Sep 05, 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000
K022502 · KZE
Equidyne Systems, Inc.
General Hospital · 38d
Cleared Sep 05, 2002
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
K022647 · HWC
Triad Medical, Inc.
Orthopedic · 27d
Cleared Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Sep 05, 2002
SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
K022766 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 15d
Cleared Sep 04, 2002
QUINTON Q-CATH, MODEL 000460
K021906 · DQK
Quinton, Inc.
Cardiovascular · 86d
Cleared Sep 04, 2002
IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K021907 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 86d
Cleared Sep 04, 2002
HRW-63-INT WRIST ARRAY COIL
K022588 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Sep 04, 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
K022621 · DQO
Boston Scientific Corp
Cardiovascular · 28d
Cleared Sep 03, 2002
BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL...
K002612 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 743d
Cleared Sep 03, 2002
EYEFEEL OPHTHALMIC WARMER
K021843 · IMD
Bio-Lipid, Inc.
Physical Medicine · 90d
Cleared Sep 03, 2002
BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES
K021847 · FCG
Biopsy Sciences, LLC
Gastroenterology & Urology · 90d
Cleared Sep 03, 2002
CLARUS STRAIGHT FIRING LASER FIBER
K021848 · GEX
Clarus Medical, LLC
General & Plastic Surgery · 90d
Cleared Sep 03, 2002
LUCIUS 62
K021948 · EJT
Lucius Metals Com.
Dental · 82d
Cleared Sep 03, 2002
SYNTHES MIDFACE DISTRACTOR
K022005 · JEY
Synthes (Usa)
Dental · 76d
Cleared Sep 03, 2002
MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
K022042 · DWF
Cardeon Corp.
Cardiovascular · 71d