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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
151969–151992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1984
RHINO-LARYNX STROBOSCOPE TYPE 4914
K842090 · EQL
Bruel & Kjaer Industri A/S
Ear, Nose, Throat · 55d
Cleared Jul 18, 1984
TYCOS SELF-CHECK/DIGITAL FEVER THERMO
K842132 · FLL
Sybron Corp.
General Hospital · 49d
Cleared Jul 18, 1984
ULTRASOUND TRANSMISSION GEL
K842153 · IYO
Wpc Brands, Inc.
Radiology · 49d
Cleared Jul 18, 1984
ELEC. DIGITAL THERMOMETER MT-20 & 30
K842199 · FLL
Sharp Electronics Corp.
General Hospital · 44d
Cleared Jul 18, 1984
ALANINE AMINOTRANSFERASE ASSAY KIT
K842241 · CKA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
UREA ASSAY KIT
K842242 · CDQ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
ALKALINE PHOSPHATASE ASSAY KIT
K842243 · CJE
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
LACTATE DENYDRO GENASE ASSAY KIT
K842244 · CFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
ASPARTATE AMINOTRANSFERASE ASSAY KIT
K842245 · CIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
URIC ACID ASSAY KIT
K842246 · KNK
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
SIGNAL ELECTRONIC CLINICAL THERMOMETER
K842317 · FLL
Yukosha Co., Inc.
General Hospital · 36d
Cleared Jul 17, 1984
HIGH FILTRATION ISO-MASK
K831148 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 466d
Cleared Jul 17, 1984
MODEL 811 VERI/TENS & PO
K840098 · GZJ
Verite
Neurology · 189d
Cleared Jul 17, 1984
COLON IRRIGATION UNIT
K840613 · KPL
Colenz Co.
Gastroenterology & Urology · 155d
Cleared Jul 17, 1984
BONE DENSITOMETER
K841463 · KGI
Norland Corp.
Radiology · 99d
Cleared Jul 17, 1984
CONFORMA
K841559 · GBI
Beiersdorf, Inc.
General & Plastic Surgery · 92d
Cleared Jul 17, 1984
HESUNG'S SOLUTION INFUSION SETS
K841563 · FPA
Amkor Trading Co.
General Hospital · 91d
Cleared Jul 17, 1984
HESUNG SCALP VEIN SET
K841564 · FPA
Amkor Trading Co.
General Hospital · 91d
Cleared Jul 17, 1984
HESUNG'S HYPERDERMIC NEEDLES
K841565 · FMI
Amkor Trading Co.
General Hospital · 91d
Cleared Jul 17, 1984
HESUNG DISPOSABLE SYRINGE
K841566 · FMF
Amkor Trading Co.
General Hospital · 91d
Cleared Jul 17, 1984
GSR, 126, EEG 130-TEMP. 132, EMG 133
K841895 · HCC
Calnor of EL Paseo, Inc.
Neurology · 71d
Cleared Jul 17, 1984
LORAD
K842102 · IZH
Lorad Medical Systems, Inc.
Radiology · 53d
Cleared Jul 17, 1984
UNIVERSAL EXAMINATION TABLE
K842108 · GZO
Engineering Dynamics Corp.
Radiology · 49d
Cleared Jul 17, 1984
SPOT-FILM DEVICE 8835
K842184 · IXL
General Electric Co.
Radiology · 46d