Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
152809–152832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1984
BRONCHOSCOPE SUCTION UNIT
K841399 · BTA
Keymed, Inc.
General & Plastic Surgery · 106d
Cleared Jul 18, 1984
IMPEDANCE/PURE TONE AUDIOMETER MA620
K841568 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 18, 1984
TERUMO DIGITAL CLINICAL THERMOMETER
K841740 · FLL
Terumo Medical Corp.
General Hospital · 82d
Cleared Jul 18, 1984
GLOTTAL FREQUENCY ANALYSER
K841832 · KLX
Teltec Electronic Equipment AB
Ear, Nose, Throat · 76d
Cleared Jul 18, 1984
IVAC 3080 ENTERAL FEEDING PUMP
K842027 · FRN
Y
General Hospital · 61d
Cleared Jul 18, 1984
ABBOTT LIFECARE 1050 CONTROLLER
K842080 · LDR
Abbott Laboratories
General Hospital · 56d
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