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
100633–100656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1995
ALTREX 110 HEMODIALYZER
K952982 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 100d
Cleared Oct 05, 1995
ALTR NOVA 110 HEMODIALYZER
K952983 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 99d
Cleared Oct 05, 1995
VISUALINE II BENZODIAZEPINES
K953105 · JXM
Sun Biomedical Laboratories, Inc.
Toxicology · 94d
Cleared Oct 05, 1995
HAWN UNIVERSAL
K953158 · DZE
Metal-Tech
Dental · 113d
Cleared Oct 05, 1995
KSEA MODEL 203200 20 UNIMAT
K953190 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 87d
Cleared Oct 05, 1995
ACUFEX TAG DELIVERY SYSTEM
K953276 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 83d
Cleared Oct 05, 1995
QBC ACCUTUBE
K953340 · GKZ
Becton Dickinson Diagnostic...
Hematology · 80d
Cleared Oct 05, 1995
UROPUMP TUBE & DAMPING CHAMGER
K953451 · FEN
Life-Tech Intl., Inc.
Gastroenterology & Urology · 79d
Cleared Oct 05, 1995
INSTANT COLDGEL
K953541 · IMD
Prism Technologies, Inc.
Physical Medicine · 69d
Cleared Oct 05, 1995
VANGUARD XR-350 CINEANGIOGRAM PROJECTOR
K953563 · IZI
Jamieson Film Co.
Radiology · 66d
Cleared Oct 05, 1995
AVL OMNI ANALYZER
K954018 · GKR
Avl Scientific Corp.
Hematology · 41d
Cleared Oct 05, 1995
TESTPACK PLUS HCG URINE
K954029 · JHI
Abbott Laboratories
Chemistry · 38d
Cleared Oct 05, 1995
MICRO-TOUCH* LATEX SURGICAL GLOVES
K954049 · KGO
Johnson & Johnson Medical, Inc.
General Hospital · 37d
Cleared Oct 05, 1995
OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
K954094 · LZU
G.W.B. Intl., Ltd.
Ophthalmic · 42d
Cleared Oct 04, 1995
INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946311 · DZE
Calcitek, Inc.
Dental · 280d
Cleared Oct 04, 1995
CHEMMATE(TM) L26 (CD20)
K950151 · DEH
Biotek Solutions, Inc.
Immunology · 260d
Cleared Oct 04, 1995
1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION
K951371 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 191d
Cleared Oct 04, 1995
3DSEE
K951646 · GCJ
Intl. Telepresence Corp.
General & Plastic Surgery · 177d
Cleared Oct 04, 1995
CC RIDER, MODEL ME180
K951916 · IKK
Mettler Electronics Corp.
Physical Medicine · 163d
Cleared Oct 04, 1995
ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE
K952072 · GEI
Zomed Intl.
General & Plastic Surgery · 155d
Cleared Oct 04, 1995
PORT-A-CATH ACCESS KIT
K952201 · FMF
Medi-Flex Hospital Products, Inc.
General Hospital · 147d
Cleared Oct 04, 1995
ERBOTOM ICC BIPOLAR
K953159 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 118d
Cleared Oct 04, 1995
STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS...
K953256 · LJS
Strato/Infusaid, Inc.
General Hospital · 84d
Cleared Oct 04, 1995
STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER...
K953436 · LJS
Strato/Infusaid, Inc.
General Hospital · 75d