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
114265–114288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1993
MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R)
K921706 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 405d
Cleared May 20, 1993
SONACE 2000
K923246 · IYO
Medison Co., Ltd.
Radiology · 322d
Cleared May 20, 1993
KANEDA ANTERIOR SPINAL MULTISEGMENTAL FIXATION DEV
K923703 · KWQ
Acromed Corp.
Orthopedic · 300d
Cleared May 20, 1993
ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED
K924358 · LIT
Cook, Inc.
Cardiovascular · 267d
Cleared May 20, 1993
PMI100 VIDEO IMAGER
K925220 · LMC
Heraeus Kulzer, Inc.
Radiology · 216d
Cleared May 20, 1993
MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT
K925945 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 177d
Cleared May 20, 1993
HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM
K926114 · DHN
Tissue Culture Biotec, Inc.
Immunology · 168d
Cleared May 20, 1993
COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS
K926443 · KHQ
Roche Diagnostic Systems, Inc.
Chemistry · 148d
Cleared May 20, 1993
FACTOR CONTROL [P]
K930959 · GGC
American Bioproducts Co.
Hematology · 85d
Cleared May 20, 1993
STATVIEW
K931060 · LMD
Image Data Corp.
Radiology · 80d
Cleared May 20, 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110 · CEC
Bio-Rad
Chemistry · 78d
Cleared May 20, 1993
MDT DENTAL CHAIR
K931169 · KLC
Mdt Corp., Inc.
Dental · 73d
Cleared May 20, 1993
VIDAS TOTAL IGE (IGE) ASSAY
K931224 · DGP
Biomerieux Vitek, Inc.
Immunology · 71d
Cleared May 20, 1993
REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK
K931290 · JTN
Remel Co.
Microbiology · 69d
Cleared May 19, 1993
BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH
K905262 · JDI
Endotec, Inc.
Orthopedic · 908d
Cleared May 19, 1993
DENTIN BONDING AGENT
K920533 · EBF
Confi-Dental Products Co.
Dental · 469d
Cleared May 19, 1993
Z-PLATE ANTERIOR FIXATION SYSTEM
K922543 · KWQ
Sofamor Danek Mfg., Inc.
Orthopedic · 355d
Cleared May 19, 1993
CROSSLINK AXIAL AND OFFSET PLATES
K923242 · KWQ
Sofamor Danek Mfg., Inc.
Orthopedic · 321d
Cleared May 19, 1993
EXTERNAL DEMAND PACEMAKER
K923621 · DTE
Oscor Medical Corp.
Cardiovascular · 302d
Cleared May 19, 1993
DISPOSABLE THERAPY ELECTRODE
K924473 · GXY
Zimmer Elektromedizin GmbH
Neurology · 261d
Cleared May 19, 1993
ELISA-DPXA SSA KIT
K924945 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SSB
K924946 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SM
K924947 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA SM/RNP
K924948 · LLL
Advanced Biological Products, Inc.
Immunology · 231d