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
83953–83976 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 2000
SOLO-CARE BRAND HARD SOLUTION
K993949 · MRC
Ciba Vision Corporation
Ophthalmic · 44d
Cleared Jan 05, 2000
VACLOK SYRINGE
K994253 · FMF
Merit Medical Systems, Inc.
General Hospital · 19d
Cleared Jan 04, 2000
TFX MEDICAL INTRODUCER KIT
K991647 · DYB
Tfx Medical Group
Cardiovascular · 236d
Cleared Jan 04, 2000
TUBING EXTENSION SET
K993361 · MSR
Hurricane Medical
Ophthalmic · 90d
Cleared Jan 04, 2000
INTRAVASCULAR ADMINISTRATION SET
K993463 · FPA
Custom Assemblies, Inc.
General Hospital · 83d
Cleared Jan 04, 2000
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
K993672 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 64d
Cleared Jan 04, 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · DYB
Boston Scientific Corp
Cardiovascular · 18d
Cleared Jan 03, 2000
QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
K993461 · JFB
Icon Intl., LLC
Physical Medicine · 82d
Cleared Jan 03, 2000
LIQUIBAND DENTAL
K993556 · EMA
Medlogic Global Corp.
Dental · 75d
Cleared Jan 03, 2000
URINALYSIS REAGENT STRIPS (10 PARAMETERS)
K993850 · JMT
International Newtech Development, Inc.
Chemistry · 52d
Cleared Jan 03, 2000
ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
K993873 · KTT
Alphatec Mfg., Inc.
Orthopedic · 49d
Cleared Jan 03, 2000
DYNATRON 900
K993919 · ITH
Dynatronics Corp.
Physical Medicine · 46d
Cleared Jan 03, 2000
CELSITE, MODELS ST401L, ST405L
K994111 · LJT
B. Braun/Mcgaw
General Hospital · 28d
Cleared Jan 03, 2000
KETAC-MOLAR QUICK
K994251 · EBF
Espe Dental AG
Dental · 17d
Cleared Dec 30, 1999
WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K993232 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 94d
Cleared Dec 30, 1999
THERMOCHEM-HT SYSTEM
K993330 · MLW
Hemocleanse, Inc.
Radiology · 87d
Cleared Dec 30, 1999
SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
K993969 · FRO
Winchester Laboratories, LLC
General & Plastic Surgery · 37d
Cleared Dec 30, 1999
DISETRONIC D-TRON INSULIN INFUSION PUMP
K994186 · LZG
Disetronic Medical Systems
General Hospital · 20d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9073
K994219 · DIO
Phamatech
Toxicology · 15d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9078
K994220 · LDJ
Phamatech
Toxicology · 15d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9068
K994233 · LAF
Phamatech
Toxicology · 14d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9083
K994234 · DJG
Phamatech
Toxicology · 14d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9133
K994236 · LCM
Phamatech
Toxicology · 14d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9063
K994237 · DKZ
Phamatech
Toxicology · 14d