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
72721–72744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2003
MODIFICATION TO TEMNO BIOPSY NEEDLES
K024120 · FCG
Allegiance Healthcare Corp.
Gastroenterology & Urology · 30d
Cleared Jan 15, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM
K024129 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 15, 2003
UNI HIP STEM
K024134 · LWJ
Plus Orthopedics
Orthopedic · 30d
Cleared Jan 15, 2003
JUPITER PROCESSING AND REVIEW WORKSTATION
K024137 · LLZ
Ge Medical Systems, Inc.
Radiology · 30d
Cleared Jan 15, 2003
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
K024161 · JWH
Implex Corp.
Orthopedic · 29d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
K024217 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219 · LKP
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118
K024221 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
K024222 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
K024224 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
K024225 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127
K024227 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
K024229 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND...
K024230 · DHN
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
TM2005 PERSONAL MEDICAL PHONE CENTER
K024365 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 15d
Cleared Jan 14, 2003
DHS DISPOSABLE HOOD SYSTEM
K021992 · FYA
Biomet, Inc.
General Hospital · 210d
Cleared Jan 14, 2003
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
K022145 · DXE
LeMaitre Vascular, Inc.
Cardiovascular · 196d
Cleared Jan 14, 2003
ENDOSCOPIC LIGHT SOURCE XL180/L3
K023468 · GCT
World of Medicine Lemke GmbH
Gastroenterology & Urology · 90d
Cleared Jan 14, 2003
ULTROID HEMORRHOID MANAGEMENT SYSTEM
K023706 · KNS
Ultroid, LLC
Gastroenterology & Urology · 71d
Cleared Jan 14, 2003
RSV OIA
K023779 · GQG
Thermo Biostar, Inc.
Microbiology · 63d
Cleared Jan 14, 2003
HL888
K023834 · DXN
Health & Life Co., Ltd.
Cardiovascular · 57d
Cleared Jan 14, 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
K023839 · GJT
Instrumentation Laboratory CO
Hematology · 57d
Cleared Jan 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
K024126 · DQO
Abbott Laboratories
Cardiovascular · 29d
Cleared Jan 14, 2003
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS,...
K024156 · DTD
Oscor, Inc.
Cardiovascular · 28d