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
105937–105960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1994
CORDIS SAVVY PTA BALLOON CATHETER
K942094 · LIT
Cordis Corp.
Cardiovascular · 183d
Cleared Nov 01, 1994
MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM
K942635 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 151d
Cleared Nov 01, 1994
MIC DISPOSABLE SNARE
K943685 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 95d
Cleared Nov 01, 1994
RIMECO MIDSTREAM URINE COLLECTOR
K943752 · FOC
Rimeco Products, Inc.
Gastroenterology & Urology · 91d
Cleared Nov 01, 1994
STERILE WATER FOR IRRATION
K943833 · JOL
Orion Life Systems, Inc.
General Hospital · 88d
Cleared Nov 01, 1994
OPTICAL FIBER FOR ENT APPLICATIONS
K944151 · GEX
Cardiogenes
General & Plastic Surgery · 84d
Cleared Nov 01, 1994
LASER DELIVERY PROBE
K944282 · GEX
Mnlase, Inc.
General & Plastic Surgery · 60d
Cleared Nov 01, 1994
THE SPACEMAKER AND THE SPACEMAKER II
K944418 · GCJ
General Surgical Innovations
General & Plastic Surgery · 54d
Cleared Nov 01, 1994
CURVD ENDOPHOTOCOGULATOR LASER PROBE
K944472 · GEX
Mnlase, Inc.
General & Plastic Surgery · 53d
Cleared Nov 01, 1994
MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER
K944621 · GEX
Mnlase, Inc.
General & Plastic Surgery · 42d
Cleared Nov 01, 1994
MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER
K944622 · GEX
Mnlase, Inc.
General & Plastic Surgery · 42d
Cleared Nov 01, 1994
MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER
K944623 · GEX
Mnlase, Inc.
General & Plastic Surgery · 42d
Cleared Nov 01, 1994
MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER
K944624 · GEX
Mnlase, Inc.
General & Plastic Surgery · 42d
Cleared Nov 01, 1994
MODEL 120-SC LASER DELIVERY PROBE
K944631 · GEX
Mnlase, Inc.
General & Plastic Surgery · 42d
Cleared Nov 01, 1994
MODEL 120-SS LASER DELIVERY PROBE
K944632 · GEX
Mnlase, Inc.
General & Plastic Surgery · 42d
Cleared Nov 01, 1994
LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR
K944688 · FFS
Progressive Dynamics, Inc.
Gastroenterology & Urology · 40d
Cleared Nov 01, 1994
CLEAR BLUE ENDOSCOPIC LENS FOG RDUCTION SOLUTION & CLEANING KIT
K944776 · FEB
Blue Planet Industries, Inc.
General Hospital · 35d
Cleared Nov 01, 1994
SURGI-LINK BIPOLAR ELECTRODES
K944898 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 28d
Cleared Nov 01, 1994
DENTAL LASER FIBER SYSTEM
K945143 · GEX
Incisive Technologies, Inc.
General & Plastic Surgery · 12d
Cleared Nov 01, 1994
4-O2 JR. (CPR MOUTH BARRIER)
K945177 · CBP
Eagle Health Supplies
Anesthesiology · 8d
Cleared Oct 31, 1994
CARD GUARD, MODEL CG-9000
K924486 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 788d
Cleared Oct 31, 1994
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
K933086 · JCM
Helena Laboratories
Hematology · 495d
Cleared Oct 31, 1994
RITCH NYLON SUTURE LASER LENS
K933264 · HJK
Ocular Instruments, Inc.
Ophthalmic · 482d
Cleared Oct 31, 1994
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3
K935599 · JJY
Clinical Controls, Inc.
Chemistry · 346d