FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94657–94680 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1997
CHASE CORONARY SINUS PERFUSION CANNULA
K964199 · DWF
Chase Medical, Inc.
Cardiovascular · 149d
Cleared Mar 19, 1997
STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL...
K964224 · GYC
Pmt Corp.
Neurology · 147d
Cleared Mar 19, 1997
HYDROPREP GEL
K964737 · GYB
D.O. Weaver Co.
Neurology · 114d
Cleared Mar 19, 1997
ENZYMUN-TEST PSA
K965085 · LTJ
Boehringer Mannheim Corp.
Immunology · 90d
Cleared Mar 19, 1997
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
K965093 · FAS
Omnitech Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 19, 1997
DAKOTA SMITH, NICOLE MILLER SUNGLASSES
K965125 · HQY
California Design Studio, Inc.
Ophthalmic · 86d
Cleared Mar 19, 1997
CUTTERSIL COMFORT
K965163 · ELW
Heraeus Kulzer, Inc.
Dental · 85d
Cleared Mar 19, 1997
CUTTERSIL COMFORT HARDENER
K965165 · ELW
Heraeus Kulzer, Inc.
Dental · 85d
Cleared Mar 19, 1997
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
K965190 · JWY
Accumed Intl., Inc.
Microbiology · 85d
Cleared Mar 19, 1997
T1 CONTROL HIGH SPEED DENTAL HANDPIECE
K965238 · EFA
Siemens AG
Dental · 78d
Cleared Mar 19, 1997
ASCEND BALLOON DAILATION CATHETER
K970041 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 19, 1997
COMEG ENDOSCOPY GRASPING FORCEPS
K970489 · FFL
Comeg Endoscopy
Gastroenterology & Urology · 37d
Cleared Mar 19, 1997
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
K970615 · LPL
Biomed Devices Corp.
Ophthalmic · 29d
Cleared Mar 18, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
K962408 · CEC
Nichols Institute Diagnostics
Chemistry · 270d
Cleared Mar 18, 1997
MOSS MIAMI SPINAL SYSTEM
K962628 · KWP
Depuy, Inc.
Orthopedic · 256d
Cleared Mar 18, 1997
GENESIS RMP
K963268 · JRA
Tecan U.S., Inc.
Chemistry · 210d
Cleared Mar 18, 1997
KENDALL DUAL LUMEN CATHETER
K963446 · MPB
Kendall Healthcare Products Co....
Gastroenterology & Urology · 196d
Cleared Mar 18, 1997
ILT ARGON HP
K964524 · EBZ
Ion Laser Technology
Dental · 126d
Cleared Mar 18, 1997
AMSINO URINARY DRAINAGE BAG
K964745 · KNX
Amsino Intl., Inc.
Gastroenterology & Urology · 112d
Cleared Mar 18, 1997
RSV ANTIGEN CONTROL SLIDES
K964870 · GQG
Viral Antigens, Inc.
Microbiology · 103d
Cleared Mar 18, 1997
VZV ANTIGEN CONTROL SLIDES
K964872 · GQW
Viral Antigens, Inc.
Microbiology · 103d
Cleared Mar 18, 1997
CMV ANTIGEN CONTROL SLIDES
K964875 · GQH
Viral Antigens, Inc.
Microbiology · 103d
Cleared Mar 18, 1997
ELECSYS TESTOSTERONE ASSAY
K964889 · CDZ
Boehringer Mannheim Corp.
Chemistry · 102d
Cleared Mar 18, 1997
THROMBONOSTIKA F1.2
K964934 · MIF
Organon Teknika Corp.
Hematology · 99d