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
75241–75264 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2002
REX, VERSION 1.0
K021099 · LLZ
Pointdx, Inc.
Radiology · 84d
Cleared Jun 27, 2002
MILLENNIUM 5000 MEUROVASCULAR COIL
K021141 · MOS
Usa Instruments, Inc.
Radiology · 79d
Cleared Jun 27, 2002
ORS-1000LD
K021288 · LHC
O.R. Solutions, Inc.
General Hospital · 65d
Cleared Jun 27, 2002
H12+HOLTER RECORDER
K021373 · MWJ
Mortara Instrument, Inc.
Cardiovascular · 57d
Cleared Jun 27, 2002
EXTENSION SET LIGHT-SAFE, MODEL BC565
K021480 · FPA
Codan US Corp.
General Hospital · 50d
Cleared Jun 27, 2002
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
K021532 · JIT
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 27, 2002
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
K021535 · JIT
Bayer Diagnostics Corp.
Chemistry · 48d
Cleared Jun 27, 2002
RDI HS CRP CALIBRATOR SET
K021607 · JIT
Reference Diagnostics, Inc.
Immunology · 42d
Cleared Jun 27, 2002
RDI HS CRP KIT
K021609 · DCK
Reference Diagnostics, Inc.
Chemistry · 42d
Cleared Jun 27, 2002
WELCH ALLYN ABPM 6100
K021756 · DXN
Welch Allyn, Inc.
Cardiovascular · 29d
Cleared Jun 27, 2002
L.E.DEMETRON
K021797 · EBZ
Sybron Dental Specialties, Inc.
Dental · 27d
Cleared Jun 27, 2002
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 24d
Cleared Jun 26, 2002
KAVO QUATTROCARE
K012308 · EFB
Kavo America
Dental · 338d
Cleared Jun 26, 2002
GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX
K014114 · FMF
Nipro Diabetes Systems, Inc.
General Hospital · 194d
Cleared Jun 26, 2002
GARD FILTER, COMBIGARD FILTE / HME
K014281 · CAH
Munktell Filter AB
General Hospital · 181d
Cleared Jun 26, 2002
BACSTOP FILTER,BACSTOP FILTER/HME
K014282 · CAH
Munktell Filter AB
General Hospital · 181d
Cleared Jun 26, 2002
DUET SUTURE ANCHOR
K020056 · HWC
Bionx Implants, Ltd.
Orthopedic · 169d
Cleared Jun 26, 2002
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K020974 · CBF
Environmental Tectonics Corp.
Anesthesiology · 92d
Cleared Jun 26, 2002
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
K021034 · KNT
Tfx Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Jun 26, 2002
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
K021036 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 86d
Cleared Jun 26, 2002
ERA IMPLANT
K021045 · DZE
Sterngold
Dental · 86d
Cleared Jun 26, 2002
KSEA NEUROENDOSCOPES AND ACCESSORIES
K021050 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 86d
Cleared Jun 26, 2002
SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM
K021137 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 26, 2002
JUMP START, MODEL 970300
K021168 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 76d