FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72841–72864 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 2003
FIRST RESPONSE PREGNANCY TEST
K030258 · LCX
Armkel, LLC
Chemistry · 32d
Cleared Feb 25, 2003
MODIFICATION TO TSRH SPINAL SYSTEM
K030285 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Feb 25, 2003
TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX
K030299 · FLL
Oriental System Technology, Inc.
General Hospital · 27d
Cleared Feb 25, 2003
UNICONDYLAR FEMORAL COMPONENT
K030301 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 24, 2003
MEDCOMP SC4
K022678 · MSD
Medcomp
Gastroenterology & Urology · 196d
Cleared Feb 24, 2003
OXYBOX SYSTEM
K023456 · KPJ
Oxyfast Corporation
General & Plastic Surgery · 132d
Cleared Feb 24, 2003
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A,...
K023931 · HGM
Philips Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Feb 24, 2003
CLOCKMINI, MODEL DF301
K023942 · MNW
Yamato Corp.
Gastroenterology & Urology · 90d
Cleared Feb 24, 2003
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210 · DGC
Beckman Coulter, Inc.
Immunology · 66d
Cleared Feb 24, 2003
WAKO L-TYPE GLUCOSE 2
K024281 · CFR
Wako Chemicals USA, Inc.
Chemistry · 63d
Cleared Feb 24, 2003
PREMIER III PHASED ARRAY CTL SPINE COIL
K030042 · MOS
Usa Instruments, Inc.
Radiology · 49d
Cleared Feb 24, 2003
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
K030182 · GGN
Bio-Rad
Hematology · 38d
Cleared Feb 24, 2003
BIORAPID MONONUCLEOSIS
K030215 · KTN
Instrumentation Laboratory CO
Immunology · 34d
Cleared Feb 21, 2003
PMH 1000 HEATED HUMIDIFIER
K013856 · BTT
Pegasus Research Corp.
Anesthesiology · 472d
Cleared Feb 21, 2003
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
K021945 · IZH
Planmed OY
Radiology · 253d
Cleared Feb 21, 2003
MACROPORE SURGICAL BARRIER FILM
K023643 · MTZ
Macropore Biosurgery, Inc.
Ophthalmic · 114d
Cleared Feb 21, 2003
SYNTRA + DIALYZER, MODEL 200
K023664 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 113d
Cleared Feb 21, 2003
COAXIA FLOCONTROL CATHETER
K023914 · MJN
Coaxia, Inc.
Cardiovascular · 88d
Cleared Feb 21, 2003
AUTOCON II 200 ELECTROSURGICAL GENERATOR
K023924 · GEI
Karl Storz Endoscopy
General & Plastic Surgery · 88d
Cleared Feb 21, 2003
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K023929 · MOS
Advanced Imaging Research, Inc.
Radiology · 88d
Cleared Feb 21, 2003
JEROME GLASS RING
K023959 · HAX
The Jerome Group, Inc.
Neurology · 86d
Cleared Feb 21, 2003
LEO III TX/RX QUADRATURE KNEE COIL
K023982 · MOS
Usa Instruments, Inc.
Radiology · 81d
Cleared Feb 21, 2003
SABER TECH IMPLANTS SYSTEM
K024044 · DZE
Imtec Corp.
Dental · 77d
Cleared Feb 21, 2003
MERIT MEDICAL 1-ML SYRINGE
K024052 · FMF
Merit Medical Systems, Inc.
General Hospital · 77d