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
135673–135696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1988
AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM
K880839 · IYO
Phoenix Imaging
Radiology · 101d
Cleared Jun 10, 1988
UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.
K881122 · BTY
Medical Associated Services, Inc.
Anesthesiology · 86d
Cleared Jun 10, 1988
HDL CHOLESTEROL KIT
K881244 · LBR
Trace Scientific , Ltd.
Chemistry · 79d
Cleared Jun 10, 1988
MODEL 9216 RESPIRATION/HEART RATE MONITOR
K881266 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 78d
Cleared Jun 10, 1988
COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK
K881330 · DWF
Cobe Laboratories, Inc.
Cardiovascular · 73d
Cleared Jun 10, 1988
OXY-CATH
K881428 · BSY
Pulmonary Medical Devices, Inc.
Anesthesiology · 66d
Cleared Jun 10, 1988
T.E.N.S. ELECTRODE NON-STERILE
K881444 · GXY
Tens Accessories, Inc.
Neurology · 65d
Cleared Jun 10, 1988
SIMPLEX UNIVERSAL HEATED TUBING SLEEVE
K881451 · BZE
Simplex Medical Corp.
Anesthesiology · 65d
Cleared Jun 10, 1988
MAMEX DC MG11
K881505 · IZH
Orion Corp.
Radiology · 60d
Cleared Jun 10, 1988
MAMEX DC MAG MG12
K881506 · IZH
Orion Corp.
Radiology · 60d
Cleared Jun 10, 1988
HUMID-VENT 2 S
K881644 · BYD
Gibeck Respiration
Anesthesiology · 56d
Cleared Jun 10, 1988
AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER
K881760 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 46d
Cleared Jun 10, 1988
DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET
K881773 · JJR
Casco Standards
Chemistry · 45d
Cleared Jun 10, 1988
IMMUNOGLOBULIN A TEST SYSTEM
K881827 · CFQ
The Binding Site, Ltd.
Immunology · 42d
Cleared Jun 10, 1988
EMIT CONVENIENCE PACK: T-UPTAKE ASSAY
K881855 · KHQ
Syva Co.
Chemistry · 38d
Cleared Jun 10, 1988
COBAS EIA(TM) PHOTOMETER
K881877 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 37d
Cleared Jun 10, 1988
IQ HDL CHOLESTEROL
K881891 · LBS
Bd Becton Dickinson Vacutainer...
Chemistry · 36d
Cleared Jun 10, 1988
PHARMACIA IGE RIACT
K881892 · DGC
Pharmacia, Inc.
Immunology · 37d
Cleared Jun 10, 1988
ACE SCREW REMOVAL TREPHINE
K882008 · HWE
Buckman Co., Inc.
Orthopedic · 28d
Cleared Jun 10, 1988
CRANK FRAME RETRACTOR
K882071 · GZT
Karlin Technology, Inc.
Neurology · 24d
Cleared Jun 10, 1988
FLOSS CARD
K882164 · JES
Arthur Blank & Co., Inc.
Dental · 17d
Cleared Jun 09, 1988
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K874165 · DXO
Deseret Medical, Inc.
Cardiovascular · 240d
Cleared Jun 09, 1988
VELEX WOVEN EXTERNAL VELOUR DACRON GRAFT
K880040 · DSY
D-R Medical Systems, Inc.
Cardiovascular · 156d
Cleared Jun 09, 1988
SHILEY FEMORAL CANNULAE INTRODUCER KIT
K881073 · DRE
Shiley, Inc.
Cardiovascular · 87d