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
116593–116616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1992
GLYCOMAT HAEMOGLOBIN ANALYSER
K920198 · LCP
Drew Scientific , Ltd.
Hematology · 188d
Cleared Jul 21, 1992
MODEL SLASE 210 HOLMIUM LASER SYSTEM
K920248 · GCX
Sunrise Technologies, Inc.
General Hospital · 182d
Cleared Jul 21, 1992
MODULAR ACETABULAR CUP SYSTEM
K920430 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 169d
Cleared Jul 21, 1992
PIM 1.0 LASER DOPPLER PERFUSION IMAGER
K920844 · DPW
Lisca Development AB
Cardiovascular · 148d
Cleared Jul 21, 1992
VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST.
K921201 · LJT
Med Institute, Inc.
General Hospital · 131d
Cleared Jul 21, 1992
WAKO AUTOKIT LIPASE-COLOR
K921249 · CHI
Wako Chemicals USA, Inc.
Chemistry · 127d
Cleared Jul 21, 1992
POTTY PAGER
K921431 · KPN
Ideas For Living
Gastroenterology & Urology · 118d
Cleared Jul 21, 1992
DIA STRIPS SYSTEM, MODIFIED
K921495 · JIO
Symcon Intl., Inc.
Chemistry · 137d
Cleared Jul 21, 1992
COOLING/HEATING THERAPY DEVICE
K921540 · ILO
Tempacure Home Care
Physical Medicine · 111d
Cleared Jul 21, 1992
OLYMPUS ISE MODULE
K921718 · JGS
Olympus Corp.
Chemistry · 103d
Cleared Jul 21, 1992
KODAK EKTACHEM DT SLIDES (NBIL)
K921844 · CIG
Eastman Kodak Company
Chemistry · 95d
Cleared Jul 21, 1992
TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH.
K921856 · LIT
Schneider Intl., Ltd.
Cardiovascular · 95d
Cleared Jul 21, 1992
MPG 65-80-100 X-RAY GENERATOR AND CONTROL
K921951 · IZO
General Electric Co.
Radiology · 85d
Cleared Jul 21, 1992
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
K922031 · JOX
Medtronic Hemotec, Inc.
Hematology · 81d
Cleared Jul 21, 1992
SALINE SOLUTION- STERILE
K922033 · CCQ
Trinity Laboratories, Inc.
Anesthesiology · 81d
Cleared Jul 21, 1992
SUNGLASSES
K922121 · HQY
Pavilion Investment , Ltd.
Ophthalmic · 77d
Cleared Jul 21, 1992
STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY
K922125 · DDR
Baxter Diagnostics, Inc.
Immunology · 76d
Cleared Jul 21, 1992
VISTA ULTRASENSITIVE HTSH ASSAY
K922138 · JLW
Syva Co.
Chemistry · 96d
Cleared Jul 21, 1992
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
K922139 · JJE
Syva Co.
Chemistry · 96d
Cleared Jul 21, 1992
EXAMINATION LAMP
K922150 · KZF
Air-Shields, Inc.
General Hospital · 75d
Cleared Jul 21, 1992
PROTECTOR SYRINGE SAFETY CAP SYSTEM
K922158 · FMI
Injectimed, Inc.
General Hospital · 75d
Cleared Jul 21, 1992
GENERAL SURGERY CLAMP AND NEEDLE HOLDER
K922659 · GDJ
Miltex Instrument Co.
General & Plastic Surgery · 48d
Cleared Jul 21, 1992
SYNERMED UIBC REAGENT KIT
K922784 · JMO
Synermed, Inc.
Chemistry · 42d
Cleared Jul 21, 1992
AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K923021 · KHO
Tosoh Corp.
Hematology · 28d