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
94225–94248 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1997
COPALIS TORC TOTAL ANTIBODY ASSAY
K970931 · LQN
Sienna Biotech, Inc.
Microbiology · 48d
Cleared Apr 23, 1997
SERVOTRONIC EC100 SYSTEM
K962087 · HWE
Medicon, Inc.
Orthopedic · 330d
Cleared Apr 23, 1997
EZ-CIRC
K963223 · HFW
Phyllis Adams, Rn, Npc, Msn
Obstetrics & Gynecology · 250d
Cleared Apr 23, 1997
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
K964152 · DGC
Pharmacia, Inc.
Immunology · 189d
Cleared Apr 23, 1997
CALL-RAD PC TELERADIOLOGY
K964288 · LMA
Pc Teleradiology
Radiology · 177d
Cleared Apr 23, 1997
THERMAL REGULATION SYSTEM BLANKET
K964377 · DWJ
Gibeck, Inc.
Cardiovascular · 173d
Cleared Apr 23, 1997
CHASE RETROGRADE CARDIOPLEGIA CANNULA
K964393 · DWF
Chase Medical, Inc.
Cardiovascular · 170d
Cleared Apr 23, 1997
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
K964756 · JFH
Wano-Tech Corp.
Chemistry · 147d
Cleared Apr 23, 1997
E-Z SPACER MASK (SMALL)
K964956 · CCQ
Airpharma, LLC
Anesthesiology · 133d
Cleared Apr 23, 1997
SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM
K965139 · HAW
Carl Zeiss, Inc.
Neurology · 121d
Cleared Apr 23, 1997
MONARCH IOL DELIVERY SYSTEM
K970033 · KYB
Alcon Laboratories
Ophthalmic · 110d
Cleared Apr 23, 1997
KENDALL HYDROPHILIC POWDER WOUND DRESSING
K970266 · KGN
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Apr 23, 1997
IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
K970292 · MBI
Influence, Inc.
Orthopedic · 89d
Cleared Apr 23, 1997
MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT
K970341 · LIS
Medtronic PS Medical
General Hospital · 84d
Cleared Apr 23, 1997
PUNCTUAL OCCLUDER
K970631 · LZU
Odyssey Medical, Inc.
Ophthalmic · 63d
Cleared Apr 23, 1997
BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE
K970930 · DYJ
Cleft Palate Appliances, Inc.
Dental · 41d
Cleared Apr 23, 1997
SMITH & NEPHEW MIS INSTRUMENTS
K970949 · GCJ
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 40d
Cleared Apr 23, 1997
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
K970969 · KOB
The Kendal Co.
Gastroenterology & Urology · 37d
Cleared Apr 23, 1997
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
K971014 · JJX
Lifescan, Inc.
Chemistry · 34d
Cleared Apr 23, 1997
LIQUID LIGAND 1,2,3
K971071 · JJY
Chiron Diagnostics Corp.
Chemistry · 30d
Cleared Apr 23, 1997
QA-ES
K971092 · GEI
Smith
General & Plastic Surgery · 28d
Cleared Apr 22, 1997
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
K941170 · DEH
Ventana Medical Systems, Inc.
Immunology · 1135d
Cleared Apr 22, 1997
CARD GUARD MODEL CG-900
K960553 · HGM
Card Guard Scientific Survival , Ltd.
Obstetrics & Gynecology · 439d
Cleared Apr 22, 1997
COAGUCHEK PST SYSTEM
K962571 · GJS
Boehringer Mannheim Corp.
Hematology · 295d