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
101281–101304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1995
DEVILBISS MODEL 5500
K946095 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 253d
Cleared Aug 24, 1995
FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
K946193 · GIL
More Diagnostics
Hematology · 247d
Cleared Aug 24, 1995
FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
K946265 · GIL
Clinical Controls, Inc.
Hematology · 244d
Cleared Aug 24, 1995
VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO...
K950153 · FPA
Imed Corp.
General Hospital · 219d
Cleared Aug 24, 1995
ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM
K950255 · HIH
Argus Medical Co., Inc.
Obstetrics & Gynecology · 213d
Cleared Aug 24, 1995
MEDI - PUMP
K950290 · CAF
Thomas Industries
Anesthesiology · 211d
Cleared Aug 24, 1995
BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)
K950897 · MMK
Biosystems
General Hospital · 178d
Cleared Aug 24, 1995
BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE)
K950898 · MMK
Biosystems
General Hospital · 178d
Cleared Aug 24, 1995
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · KLI
Bio-Rad
Chemistry · 154d
Cleared Aug 24, 1995
FLOLAB
K951442 · EXY
Synectics Medical, Inc.
Gastroenterology & Urology · 148d
Cleared Aug 24, 1995
SWISS LITHOCLAST LITHOTRIPTER
K951531 · FFK
Electro Medical Systems SA
Gastroenterology & Urology · 143d
Cleared Aug 24, 1995
ROLLER ELECTRODE
K951863 · FAS
Olympus America, Inc.
Gastroenterology & Urology · 125d
Cleared Aug 24, 1995
ADVANTAGE TEST STRIPS
K951887 · LFR
Boehringer Mannheim Corp.
Chemistry · 122d
Cleared Aug 24, 1995
LYFO(TM) DIFFERENTIAL DISK
K951889 · JTO
Microbiologics, Inc.
Microbiology · 122d
Cleared Aug 24, 1995
ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
K952253 · LLL
Helix Diagnostics, Inc.
Immunology · 101d
Cleared Aug 24, 1995
SPLASH ASSIST
K952303 · LYU
Innovative Outsourcing Solutions
General Hospital · 100d
Cleared Aug 24, 1995
HI-LINE MEDICAL PHACOEMULSIFIER TIP
K952468 · HQC
Hi-Line Medical
Ophthalmic · 90d
Cleared Aug 24, 1995
TOX PERFECT B TUBES AND REAGENTS
K952501 · DPM
Chimera Research & Chemical, Inc.
Chemistry · 86d
Cleared Aug 24, 1995
QUEST VEIN GRAFT PERFUSION SET
K952531 · DTL
Quest Medical, Inc.
Cardiovascular · 84d
Cleared Aug 24, 1995
AQUISEN
K952583 · LJH
Aquintel, Inc.
Gastroenterology & Urology · 80d
Cleared Aug 24, 1995
ALKPHASE-B ASSAY KIT
K952768 · CIN
Metra Biosystems, Inc.
Chemistry · 71d
Cleared Aug 24, 1995
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
K952839 · DML
Boehringer Mannheim Corp.
Toxicology · 64d
Cleared Aug 24, 1995
CSF LIQUID CEREBROSPINAL FLUID CONTROL
K952877 · JJY
Medical Analysis Systems, Inc.
Chemistry · 62d
Cleared Aug 24, 1995
AXSYM THEOPHYLLINE II
K953016 · LGS
Abbott Laboratories
Toxicology · 56d