FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
91729–91752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1997
CM & CM DS-7
K963914 · IXA
Konica Medical Corp.
Radiology · 373d
Cleared Oct 08, 1997
GELBFISH ENDO-VAC SYSTEM
K970233 · MCW
Gary A. Gelbfish
Cardiovascular · 260d
Cleared Oct 08, 1997
INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
K971273 · DQA
Bio-Tek Instruments, Inc.
Anesthesiology · 184d
Cleared Oct 08, 1997
COEUR 130 ML ANGIOGRAPHIC SYRINGE
K971712 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 152d
Cleared Oct 08, 1997
LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
K971877 · DTZ
Dideco S.P.A.
Cardiovascular · 140d
Cleared Oct 08, 1997
ACU-RAY HF SERIES PORTABLE X-RAY UNIT
K972204 · IZL
Sterne Equipment Co., Ltd.
Radiology · 118d
Cleared Oct 08, 1997
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
K972569 · EGS
Nsk Nakanishi, Inc.
Dental · 90d
Cleared Oct 08, 1997
DISSECTRON PORTABLE UNIT
K972612 · LBK
Satelec
Neurology · 86d
Cleared Oct 08, 1997
MANIFOLD
K972654 · DTL
Medical Specialties Intl., Inc.
Cardiovascular · 85d
Cleared Oct 08, 1997
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K972726 · JSM
Medical Packaging Corp.
Microbiology · 79d
Cleared Oct 08, 1997
DEY VIAL SODIUM CHLORIDE 3%
K972778 · CAF
Dey Laboratories, Inc.
Anesthesiology · 75d
Cleared Oct 08, 1997
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
K972815 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 72d
Cleared Oct 08, 1997
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER...
K972922 · EMX
Interview Medical Technology Corp.
Ear, Nose, Throat · 61d
Cleared Oct 08, 1997
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
K972926 · FBN
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 61d
Cleared Oct 08, 1997
ROTOGRAPH PLUS
K972968 · EHD
Chicago X-Ray Systems, Inc.
Radiology · 58d
Cleared Oct 08, 1997
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K972986 · MJX
Boston Biomedica, Inc.
Microbiology · 58d
Cleared Oct 08, 1997
DRTS IMAGE INTENSIFIER DRAPE
K973073 · JAA
Minrad, Inc.
Radiology · 51d
Cleared Oct 08, 1997
MAMMOLOADER BY C.M.A. SRL
K973125 · IXW
C.M.A.
Radiology · 49d
Cleared Oct 08, 1997
AMBER DU
K973219 · KPR
Oldelft Corp. of America
Radiology · 42d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
K973327 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
K973329 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
DAR-3000B
K973342 · IZI
Shimadzu Corp.
Radiology · 33d
Cleared Oct 08, 1997
LIQUID LDH-L REAGENT SET
K973589 · CFJ
Pointe Scientific, Inc.,
Chemistry · 16d
Cleared Oct 07, 1997
TACTYLON CONDOM
K971590 · MOL
Sensicon Corp.
Obstetrics & Gynecology · 159d