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
73225–73248 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2003
REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE
K023952 · DZE
Nobel Biocare Uas, Inc.
Dental · 50d
Cleared Jan 16, 2003
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
K024200 · OWB
Ge Medical Systems, Inc.
Radiology · 27d
Cleared Jan 16, 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · DRX
Leonhard Lang GmbH
Cardiovascular · 24d
Cleared Jan 16, 2003
SKINTACT
K024264 · DRX
Leonhard Lang Co.
Cardiovascular · 24d
Cleared Jan 15, 2003
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
K021555 · DXX
Stereotaxis, Inc.
Cardiovascular · 247d
Cleared Jan 15, 2003
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
K023289 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 105d
Cleared Jan 15, 2003
AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
K023482 · GEI
Kirwan Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jan 15, 2003
NUAMPS
K023536 · OLT
Neuroscan
Neurology · 86d
Cleared Jan 15, 2003
RHEUMATOID FACTOR (RF)
K024067 · DHR
Abbott Laboratories
Immunology · 36d
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