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
70969–70992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2003
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K031355 · NKB
Ebi, L.P.
Orthopedic · 84d
Cleared Jul 22, 2003
EBI SPINELINK SPINAL FIXATION SYSTEM
K031424 · NKB
Ebi, L.P.
Orthopedic · 77d
Cleared Jul 22, 2003
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
K032103 · DSH
Philips Medical Systems
Cardiovascular · 14d
Cleared Jul 21, 2003
TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
K024377 · QJQ
Kalaco Scientific, Inc.
Neurology · 202d
Cleared Jul 21, 2003
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
K030033 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 199d
Cleared Jul 21, 2003
ORLON NONABSORABLE SURGICAL SUTURE USP
K030177 · GAR
Sri Orion Pharmaceuticals & Sutures
General & Plastic Surgery · 185d
Cleared Jul 21, 2003
SAPPHIRE DETACHABLE COIL SYSTEM
K030392 · HCG
Micro Therapeutics, Inc.
Neurology · 166d
Cleared Jul 21, 2003
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K030442 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 160d
Cleared Jul 21, 2003
ENDOS DC
K030634 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 144d
Cleared Jul 21, 2003
FAST THROW STAINLESS STEEL SURGICAL SUTURE
K030926 · FZP
Advanced Surgical Products, Inc.
General & Plastic Surgery · 119d
Cleared Jul 21, 2003
GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)
K031085 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 108d
Cleared Jul 21, 2003
MODIFICATION TO STRYKER PAINPUMP
K031249 · FRN
Stryker Instruments
General Hospital · 94d
Cleared Jul 21, 2003
DUNLEE FORMAT COLLIMATOR FAMILY
K031597 · IZW
Philips Medical Systems North America...
Radiology · 61d
Cleared Jul 21, 2003
SLED CURING LIGHT SYSTEM
K031615 · EBZ
Dentsply International
Dental · 59d
Cleared Jul 21, 2003
CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION
K031638 · LLZ
Electromed Imaging, Inc.
Radiology · 55d
Cleared Jul 21, 2003
CORIX 70 PLUS-USV
K031802 · EHD
Coramex, S.A.
Radiology · 40d
Cleared Jul 21, 2003
CARDIOVATIONS OPTICAL BIPOLAR DEVICE
K031846 · GEI
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jul 21, 2003
CARDIOVATIONS RETRACTOR
K031847 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Jul 21, 2003
BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE...
K031912 · LON
Becton, Dickinson & CO
Microbiology · 31d
Cleared Jul 21, 2003
AMPLAID A756 SCREENING ADMITTANCE METER
K031978 · ETY
Amplaid
Ear, Nose, Throat · 25d
Cleared Jul 21, 2003
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
K032114 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Jul 21, 2003
BRODA MODEL 587 MANUAL WHEELCHAIR
K032133 · IOR
Broda Ent., Inc.
Physical Medicine · 10d
Cleared Jul 21, 2003
SITE-RITE IV ULTRASOUND SYSTEM
K032135 · IYO
Dymax Corp
Radiology · 10d
Cleared Jul 18, 2003
DIADEXUS PLAC TEST
K030477 · NOE
Diadexus, Inc.
Chemistry · 155d