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
117961–117984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1992
OPTION U1 FOR THE DPS-PLUS SYSTEM
K915305 · LLZ
Adac Laboratories
Radiology · 97d
Cleared Feb 26, 1992
AMMONIA REAGENT SET
K915707 · JIF
Tech Intl. Co.
Chemistry · 89d
Cleared Feb 25, 1992
NMC CYCLER MACHINE
K905809 · FKX
National Medical Care, Medical...
Gastroenterology & Urology · 425d
Cleared Feb 25, 1992
NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE
K913407 · FPD
Sandoz Nutrition
Gastroenterology & Urology · 210d
Cleared Feb 25, 1992
ACCESS IMPRESSION BARREL
K913974 · EID
Centrix, Inc.
Dental · 172d
Cleared Feb 25, 1992
GASTROINTESTINAL TUBE AND ACCESSORIES
K914492 · FPD
Sandoz Nutrition
Gastroenterology & Urology · 140d
Cleared Feb 25, 1992
EXCEL MODEL XLT-ONE ND:YAG LASER SYSTEM
K914849 · GEX
Excel Tech. , Ltd.
General & Plastic Surgery · 120d
Cleared Feb 25, 1992
NASOGASTRIC FEEDING TUBE KITS
K915439 · FPD
Sandoz Nutrition
Gastroenterology & Urology · 85d
Cleared Feb 25, 1992
PROVICOL
K915618 · EMA
Voco GmbH
Dental · 71d
Cleared Feb 25, 1992
IONOFIL/LONOFIL MOLAR
K915619 · EMA
Voco GmbH
Dental · 71d
Cleared Feb 25, 1992
EZ GOLD
K915626 · EJT
Ivoclar North America, Inc.
Dental · 70d
Cleared Feb 24, 1992
URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
K912888 · MIG
Dynagen, Inc.
Toxicology · 238d
Cleared Feb 24, 1992
STERILE DISPOSABLE WET SKIN SCRUB TRAY
K914174 · LRO
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 159d
Cleared Feb 24, 1992
SELECTACUT BIOPSY DEVICE
K914215 · KNW
Biomni Medical Systems, Inc.
Gastroenterology & Urology · 158d
Cleared Feb 24, 1992
STERILE CUSTOM SURGICAL KITS
K914244 · KDD
Ulti-Med Intl., Inc.
General & Plastic Surgery · 154d
Cleared Feb 24, 1992
DRS-4 DIALYZER REPROCESSING SYSTEM
K914580 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 131d
Cleared Feb 24, 1992
LATERALASE
K915354 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 90d
Cleared Feb 24, 1992
FEEDING TUBE Y-PORT CONNECTOR
K915438 · FPD
Sandoz Nutrition
Gastroenterology & Urology · 84d
Cleared Feb 24, 1992
PHACO 20/20 SYSTEM I
K915457 · HQC
Innovative Medical Systems, Inc.
Ophthalmic · 81d
Cleared Feb 24, 1992
URETHRALPRESSURE PROFILE CATHETER
K915484 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 80d
Cleared Feb 24, 1992
VISITEC CANALICULAR STENT
K915809 · LZU
Visitec Co.
Ophthalmic · 62d
Cleared Feb 21, 1992
NGM ESTP MODULE
K911646 · MHX
Datex Division Instrumentarium Corp.
Cardiovascular · 312d
Cleared Feb 21, 1992
ECONOMATE/PATRIOT
K912794 · CAW
Foothills Medical Equipment, Inc.
Anesthesiology · 241d
Cleared Feb 21, 1992
MODEL SLASE 210 HOLMIUM (THC:YAG) LASER SYSTEM
K912879 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 235d