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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133441–133464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1988
PERMANENT PACING LEAD MODEL RXBJ SERIES
K882462 · DTB
Oscor Medical Corp.
Cardiovascular · 135d
Cleared Oct 28, 1988
COMPAT ENTERAL DELIVERY SYSTEM
K882682 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 122d
Cleared Oct 28, 1988
0.014 PERIPHERAL GUIDE WIRE
K882804 · DQX
Intensive Technology, Inc.
Cardiovascular · 113d
Cleared Oct 28, 1988
SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEM
K883058 · CAC
Solco Basle, Inc.
Anesthesiology · 101d
Cleared Oct 28, 1988
PMT 3721-1 EPIDURAL KIT
K883314 · CAZ
Progress Mankind Technology
Anesthesiology · 85d
Cleared Oct 28, 1988
PORGES STEPPED NEOPLEX DILATOR
K883526 · KNQ
Porges Corp.
Gastroenterology & Urology · 71d
Cleared Oct 28, 1988
BM-103 BATTERY MODULE
K883877 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 45d
Cleared Oct 28, 1988
3D VASCULAR RECORDER
K883908 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 43d
Cleared Oct 28, 1988
ROTATING HEMOSTATIC VALVE
K883916 · DQY
Devices For Vascular Intervention, Inc.
Cardiovascular · 42d
Cleared Oct 28, 1988
BIO-MEDICUS TUBING CONNECTORS
K883956 · DTL
Bio Medicus, Inc.
Cardiovascular · 39d
Cleared Oct 28, 1988
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
K884167 · CBN
Technical Medical Products, Inc.
Anesthesiology · 24d
Cleared Oct 27, 1988
SCALP HYDROBATH/TREATMENT DELIVERY SYSTEM
K883187 · ILJ
Intl. Health Technology, Inc.
Physical Medicine · 91d
Cleared Oct 27, 1988
MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10)
K883371 · DHB
3M Company
Immunology · 78d
Cleared Oct 27, 1988
MICROMEDIC FERRITIN IRMA KIT
K883746 · DBF
Icn Micromedic Systems
Immunology · 56d
Cleared Oct 27, 1988
MODIFIED MODEL 2001 FIBER OPTICS CATHETER
K883881 · GWM
Metatech Corp.
Neurology · 90d
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883 · LKJ
Immco Diagnostics, Inc.
Immunology · 44d
Cleared Oct 27, 1988
INFUSA-PLATE
K883902 · FRN
Kalajian Ent.
General Hospital · 42d
Cleared Oct 27, 1988
SCEPTORPETTE SYSTEM
K883907 · LRG
Bd Becton Dickinson Vacutainer...
Microbiology · 42d
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949 · LKJ
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Oct 27, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
K884074 · DAH
Orion Diagnostica, Inc.
Immunology · 30d
Cleared Oct 27, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M
K884147 · DFT
Orion Diagnostica, Inc.
Chemistry · 24d
Cleared Oct 27, 1988
CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY
K884185 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 23d
Cleared Oct 27, 1988
MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS
K884311 · GEX
Surgilase, Inc.
General & Plastic Surgery · 14d
Cleared Oct 27, 1988
MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS
K884313 · GEX
Surgilase, Inc.
General & Plastic Surgery · 14d