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
114193–114216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1993
DLX
K926258 · IZI
GE Medical Systems
Radiology · 87d
Cleared Mar 15, 1993
ENDOSCOPE AND ACCESSORIES
K930082 · GCJ
Weck Endoscopy
General & Plastic Surgery · 67d
Cleared Mar 15, 1993
QUANTA LITE(TM) THYROID T ELISA
K930486 · DDC
Inova Diagnostics, Inc.
Immunology · 45d
Cleared Mar 12, 1993
PEG GASTROSTOMY TUBE KIT
K915308 · FPD
Sandoz Nutrition
Gastroenterology & Urology · 477d
Cleared Mar 12, 1993
AUTOTRANSFUSION SUCTION SET
K920618 · CAC
Lifestream Int'L, Inc.
Anesthesiology · 395d
Cleared Mar 12, 1993
SARNS RETROGRADE CANNULA - AUTO INFLATE
K922471 · DWF
3M Health Care, Sarns
Cardiovascular · 290d
Cleared Mar 12, 1993
MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
K922482 · LRG
Baxter Diagnostics, Inc.
Microbiology · 289d
Cleared Mar 12, 1993
BIOACTION LOW PROFILE SCREW SYSTEM
K922788 · HWC
Orthopaedic Biosystems
Orthopedic · 276d
Cleared Mar 12, 1993
NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY
K923532 · JLW
Solarcare Technologies Corp,Inc.
Chemistry · 239d
Cleared Mar 12, 1993
SAVACARE LATEX EXAMINATION GLOVES
K924233 · LYY
Preventive Care, Inc.
General Hospital · 200d
Cleared Mar 12, 1993
ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
K925604 · GJS
Ortho Diagnostic Systems, Inc.
Hematology · 127d
Cleared Mar 12, 1993
OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT
K925893 · CAI
Oem Medical Div.
Anesthesiology · 115d
Cleared Mar 11, 1993
ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
K913766 · LYY
Ansell, Inc.
General Hospital · 567d
Cleared Mar 11, 1993
BIRD 8400ST ADULT VOLUME VENTILATOR
K921387 · CBK
Bird Products Corp.
Anesthesiology · 353d
Cleared Mar 11, 1993
RETRIEVER 10
K921649 · DQO
Target Therapeutics
Cardiovascular · 339d
Cleared Mar 11, 1993
MEDGRAPHICS EXERCISE CONSULT
K923209 · BZM
Medical Graphics Corp.
Anesthesiology · 253d
Cleared Mar 11, 1993
ULTRAGOLD
K923817 · EJT
J.F. Jelenko & Co., Inc.
Dental · 224d
Cleared Mar 11, 1993
VARIANT BETA-THALASSEMIA SHORT PROGRAM
K924122 · JPD
Bio-Rad
Hematology · 209d
Cleared Mar 11, 1993
API 20E/UNISCEPT 20E
K924814 · JSS
Analytical Products, Inc.
Microbiology · 167d
Cleared Mar 11, 1993
CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM
K926017 · JSS
Becton Dickinson Microbiology Systems
Microbiology · 101d
Cleared Mar 11, 1993
CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM
K926018 · JSS
Becton Dickinson Microbiology Systems
Microbiology · 101d
Cleared Mar 11, 1993
AID, CARDIOPULMONARY RESUSCITATION
K930429 · BTM
Valley Forge Scientific Corp.
Anesthesiology · 44d
Cleared Mar 11, 1993
MED-PLASTICS INTL., INC. BREATHING FILTER
K930760 · CAH
Med-Plastics Intl., Inc.
General Hospital · 27d
Cleared Mar 10, 1993
YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH
K923894 · GWQ
Biosound, Inc.
Neurology · 218d