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
113089–113112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 1993
CASCADE M, CAT. NO. 1710
K931956 · GKP
Helena Laboratories
Hematology · 125d
Cleared Aug 23, 1993
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY
K932030 · GKZ
Coulter Corp.
Hematology · 118d
Cleared Aug 23, 1993
EYE SPOT CRP TEST
K932180 · DCN
J.S. Medical Assoc.
Immunology · 110d
Cleared Aug 23, 1993
CORDIS TUNNELER
K932273 · GYK
Cordis Corp.
Neurology · 102d
Cleared Aug 23, 1993
SYLNELISA HISTONE ANTIBODIES
K932302 · LKJ
Elias U.S.A., Inc.
Immunology · 103d
Cleared Aug 23, 1993
EYE SPOT RF TEST
K932437 · DHR
J & S Medical Assoc., Inc.
Immunology · 96d
Cleared Aug 23, 1993
RHEUMELISA II HISTONE ANTIBODY TEST KIT
K932679 · LKJ
Biowhittaker Molecular Applications,...
Immunology · 82d
Cleared Aug 23, 1993
SYNELISA TG ANTIBODIES/TPO ANTIBODIES
K933123 · JZS
Elias U.S.A., Inc.
Immunology · 56d
Cleared Aug 23, 1993
MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID
K933291 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 48d
Cleared Aug 23, 1993
MULTIFOCUS COMPACT BTE HEARING AID
K933307 · ESD
Oticon, Inc.
Ear, Nose, Throat · 47d
Cleared Aug 23, 1993
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447 · OXO
GE Medical Systems
Radiology · 41d
Cleared Aug 23, 1993
MEMOREX ARTISAN SYSTEM/ARTISAN PROGRAMMER AND CUSTOM HEARING AID
K933579 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 31d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 12 (L12)
K933640 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 6 (L6)
K933643 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 23, 1993
WIDEX MODEL LOGO 8 (L8)
K933644 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 27d
Cleared Aug 20, 1993
B-D ARTERIAL BLOOD CONTAINMENT DEVICE
K925947 · DQX
Bd Becton Dickinson Vacutainer...
Cardiovascular · 269d
Cleared Aug 20, 1993
MEDTRONIC MODEL 3990 PNS LEAD
K925952 · GZF
Medtronic Vascular
Neurology · 269d
Cleared Aug 20, 1993
SIGMA MP MULTIPLACE HYPERBARIC CHAMBER
K930748 · CBF
Perry Baromedical Services
Anesthesiology · 189d
Cleared Aug 20, 1993
HATCHER STONE-EMBOLIS EXTRACTOR
K931115 · LQR
Ideal Medical, Inc.
Gastroenterology & Urology · 169d
Cleared Aug 20, 1993
CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP
K931132 · FRN
Pharmacia Deltec, Inc.
General Hospital · 168d
Cleared Aug 20, 1993
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER
K931619 · GCA
Boston Scientific Corp
Gastroenterology & Urology · 140d
Cleared Aug 20, 1993
HALUX TASKLIGHT
K931645 · KZF
Burton Medical Products Corp.
General Hospital · 140d
Cleared Aug 20, 1993
MEDWAY OXYGEN MASK
K931952 · BYG
Medway
Anesthesiology · 122d
Cleared Aug 20, 1993
GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION
K931991 · HAW
Nomos Corp.
Neurology · 120d