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
135217–135240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1988
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
K880823 · KXT
Amersham Corp.
Toxicology · 91d
Cleared May 31, 1988
CONTRAST INJECTION DEVICE
K880877 · DXT
Med-West, Inc.
Cardiovascular · 91d
Cleared May 31, 1988
MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE
K880930 · HHR
Copper Lasersonics, Inc.
Obstetrics & Gynecology · 88d
Cleared May 31, 1988
SHILEY FEMORAL ARTERIAL CANNULA
K881072 · DWF
Shiley, Inc.
Cardiovascular · 78d
Cleared May 31, 1988
SHILEY FEMORAL VENOUS CANNULA
K881074 · DWF
Shiley, Inc.
Cardiovascular · 78d
Cleared May 31, 1988
ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
K881088 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 77d
Cleared May 31, 1988
GAMMA GLUTAMYL TRANSFERASE REAGENT SET
K881239 · JPZ
Tech-Neal Scientific, Inc.
Chemistry · 70d
Cleared May 31, 1988
RANEY CLIPS
K881265 · HBO
Zimmer, Inc.
Neurology · 68d
Cleared May 31, 1988
CARDICAD(TM)
K881392 · DWS
Medical/Surgical Specialties, Ltd.
Cardiovascular · 57d
Cleared May 31, 1988
CRANIOTOME BLADE OR NEURO BLADE
K881418 · HBE
Nuell Air Equipment & Hospital...
Neurology · 57d
Cleared May 31, 1988
LINDER NASOTRACHEAL AIRWAY
K881496 · BTR
Polamedco, Inc.
Anesthesiology · 53d
Cleared May 31, 1988
MODIFIED SERVO SYRINGE
K881521 · DXT
Engineering, Inc.
Cardiovascular · 53d
Cleared May 31, 1988
EPICARDIA LE/FD
K881770 · DQK
Medicomp, Inc.
Cardiovascular · 35d
Cleared May 31, 1988
N.S. CADEE
K881785 · FMI
First Scientific, Div.
General Hospital · 35d
Cleared May 31, 1988
UVMAX KINETIC MICROPLATE READER
K881803 · JJQ
Molecular Devices Corp.
Chemistry · 33d
Cleared May 31, 1988
MSI 5000 SERIES BED
K881965 · FNL
Med Service, Inc.
General Hospital · 21d
Cleared May 31, 1988
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
K882019 · IXR
General Electric Co.
Radiology · 18d
Cleared May 27, 1988
LIPASE UV [TOYO]
K874027 · CHI
Advocacy International, Ltd.
Chemistry · 238d
Cleared May 27, 1988
ABBOTT BREATH ACETONE ANALYZER
K875029 · JIN
Abbott Laboratories
Chemistry · 172d
Cleared May 27, 1988
MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM
K875181
Marion Laboratories, Inc.
Toxicology · 162d
Cleared May 27, 1988
DART PHENYTOIN
K880294 · LFO
Coulter Electronics, Inc.
Chemistry · 123d
Cleared May 27, 1988
CALCIUM
K880308 · CIC
Catachem, Inc.
Chemistry · 123d
Cleared May 27, 1988
MULTI-FUNCTION BLOOD GAS CONTROL
K880447 · JJY
Bionostics, Inc.
Chemistry · 115d
Cleared May 27, 1988
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
K880692 · CIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 95d