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
110569–110592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1994
HELICAL STONE/FLATWIRE STONE BASKETS
K933260 · FFL
Surgitek
Gastroenterology & Urology · 189d
Cleared Jan 11, 1994
GRASPING FORCEPS
K933261 · FGO
Surgitek
Gastroenterology & Urology · 189d
Cleared Jan 11, 1994
ACS POWERGUIDE CORONARY GUIDING CATHETER
K934009 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 146d
Cleared Jan 11, 1994
N-ASSAY TIA MICROALBUMIN
K934146 · JIR
Crestat Diagnostics, Inc.
Chemistry · 140d
Cleared Jan 11, 1994
ENDOMEDIX Y-ADAPTER
K934170 · OCX
Endomedix
Gastroenterology & Urology · 137d
Cleared Jan 11, 1994
KARL STORZ ENDOSCOPIC COLD KNIFE BLADES
K934730 · EZO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 102d
Cleared Jan 11, 1994
RELIEF PLUS ONE REAGENT STRIP MODIFICATION
K934892 · CGA
Diagnostic Solutions, Inc.
Chemistry · 113d
Cleared Jan 11, 1994
SPQ PAL CONTROL LEVEL II
K934966 · DDS
Incstar Corp.
Immunology · 88d
Cleared Jan 11, 1994
MODEL 5500 CEAS
K934977 · CDF
Esa, Inc.
Chemistry · 84d
Cleared Jan 11, 1994
SPQ CRP CONTROL LEVEL II
K935075 · DCN
Incstar Corp.
Immunology · 78d
Cleared Jan 11, 1994
DIRECTDRAW SUPERSERUM-MINI
K935081 · JKA
International Technidyne Corp.
Chemistry · 78d
Cleared Jan 11, 1994
ONE STEP LH TEST
K935134 · CEP
Tcpi, Inc.
Chemistry · 75d
Cleared Jan 11, 1994
IMMULITE PROGESTERONE
K935138 · JLS
Diagnostic Products Corp.
Chemistry · 75d
Cleared Jan 11, 1994
CEDIA(R) DAU OPIATE ASSAY
K935346 · DJG
Microgenics Corp.
Toxicology · 67d
Cleared Jan 11, 1994
CREATINE KINASE-MB (CK-MB) REAGENT SET
K935463 · CGS
Pointe Scientific, Inc.,
Chemistry · 60d
Cleared Jan 10, 1994
ACE BASIC DENTAL IMPLANT PACK II
K922649 · EIA
Ace Surgical Supply Co., Inc.
Dental · 586d
Cleared Jan 10, 1994
ACE DENTAL IMPLANT CUSTOM SURGICAL PACK
K922650 · EIA
Ace Surgical Supply Co., Inc.
Dental · 586d
Cleared Jan 10, 1994
ACE DENTAL IMPLANT KIT
K922651 · EIA
Ace Surgical Supply Co., Inc.
Dental · 586d
Cleared Jan 10, 1994
ACE BASIC DENTAL IMPLANT PACK I
K922652 · EIA
Ace Surgical Supply Co., Inc.
Dental · 586d
Cleared Jan 10, 1994
CHOLESTEROL ENZYMATIC ENDPOINT
K923504 · CHH
Randox Laboratories, Ltd.
Chemistry · 544d
Cleared Jan 10, 1994
EVITA
K924930 · CBK
Drager, Inc.
Anesthesiology · 467d
Cleared Jan 10, 1994
INAMED DEVELOPMENT ASPIRATION TIP
K931548 · GCX
Inamed Development Co.
General Hospital · 287d
Cleared Jan 10, 1994
EZ ADMINISTRATION SET
K931550 · FPA
Y
General Hospital · 287d
Cleared Jan 10, 1994
GIANTURCO-HELFRICH HERNIS MESH
K931936 · FTL
Cook, Inc.
General & Plastic Surgery · 266d