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
127009–127032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1990
COBAS READY BUN REAGENT
K896236 · JGZ
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 27, 1990
CMV IGM ELISA TEST SYSTEM
K896355 · LFZ
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Feb 27, 1990
KEY VASCULAR LOOPS
K896676 · KDC
Key Surgical, Inc.
General & Plastic Surgery · 92d
Cleared Feb 27, 1990
RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE
K896777 · DWF
Research Medical, Inc.
Cardiovascular · 88d
Cleared Feb 27, 1990
RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE
K896778 · DWF
Research Medical, Inc.
Cardiovascular · 88d
Cleared Feb 27, 1990
QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3
K896956 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 75d
Cleared Feb 27, 1990
SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
K897110 · CEM
Medisense, Inc.
Chemistry · 63d
Cleared Feb 27, 1990
CONVERTIBLE ADAPTER CATALOG NO. 48-4039-3
K900004 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 56d
Cleared Feb 27, 1990
CATHETER ADAPTER SEALING CAP NO. 48-1028-9
K900006 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 56d
Cleared Feb 27, 1990
MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
K900129 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 55d
Cleared Feb 27, 1990
DIRECT BILIRUBIN REAGENT
K900259 · CIG
Medical Analysis Systems, Inc.
Chemistry · 41d
Cleared Feb 27, 1990
INFRAVIB MASSAGER - MODEL PR-1000
K900384 · ILY
Infralux International, Inc.
Physical Medicine · 29d
Cleared Feb 27, 1990
CRYOTRON-UL30
K900419 · IMF
Henley Intl.
Physical Medicine · 28d
Cleared Feb 27, 1990
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
K900422 · CZP
Helena Laboratories
Immunology · 28d
Cleared Feb 27, 1990
JYROCHAIR POWER WHEELCHAIR
K900514 · ITI
Jyrochair, Inc.
Physical Medicine · 25d
Cleared Feb 27, 1990
MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP.
K900523 · HQY
J & B Assoc.
Ophthalmic · 25d
Cleared Feb 27, 1990
MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE
K900525 · HQY
J & B Assoc.
Ophthalmic · 25d
Cleared Feb 27, 1990
AUTOREADER CALIBRATION TEST PLATE
K900579 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 20d
Cleared Feb 26, 1990
DUAL GUIDE INTRODUCER CATHETER
K895044 · DYB
Cook, Inc.
Cardiovascular · 201d
Cleared Feb 26, 1990
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379 · LDD
Physio-Control Corp.
Cardiovascular · 180d
Cleared Feb 26, 1990
NOBLES-LAI ENGINEERING INFUSION PUMP
K895688 · DQI
Nobles-Lai Engineering, Inc.
General Hospital · 157d
Cleared Feb 26, 1990
SMALL CATHETER INFLATOR
K896005 · MAV
Allied Systems Co.
Cardiovascular · 136d
Cleared Feb 26, 1990
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
K896097 · GQG
Vitek Systems, Inc.
Microbiology · 129d
Cleared Feb 26, 1990
1400 SERIES EVIDENCE COLLECTION KIT
K896373 · GIM
Transidyne General Corp.
Pathology · 112d