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
97849–97872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 1996
MODEL 1220, OR E-NET (54-62 CM)
K961609 · GXY
Physiometrix, Inc.
Neurology · 15d
Cleared May 10, 1996
JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY
K961683 · LRO
J.J. Skinner, Inc.
General & Plastic Surgery · 9d
Cleared May 09, 1996
ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY...
K935720 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 891d
Cleared May 09, 1996
VYGON LIFEVAC MID-LINE TRAY
K954112 · FOZ
Vygon Corp.
General Hospital · 283d
Cleared May 09, 1996
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT &...
K954771 · BSR
Laerdal Medical Corp.
Anesthesiology · 205d
Cleared May 09, 1996
ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE...
K955092 · LLZ
Cemax-Icon, Inc.
Radiology · 184d
Cleared May 09, 1996
ANALYTICAL REVIEW STATION
K955519 · IZI
Camtronics, Ltd.
Radiology · 157d
Cleared May 09, 1996
AXSYM VANCOMYCIN II
K955851 · LEH
Abbott Laboratories
Toxicology · 134d
Cleared May 09, 1996
THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
K960518 · BZD
Puritan Bennett Corp.
Anesthesiology · 94d
Cleared May 09, 1996
KANGAROO FEEDING TUBE PLACMENT STYLET
K960632 · KNT
Sherwood Medical Co.
Gastroenterology & Urology · 85d
Cleared May 09, 1996
OSAP
K960673 · LQZ
Snorefree, Inc.
Dental · 79d
Cleared May 09, 1996
ISOLAIR APR TYPE N95
K960778 · MSH
Louis M. Gerson Co., Inc.
General Hospital · 73d
Cleared May 09, 1996
ORTHO-ICE
K960799 · EAT
Ultimate Wireforms, Inc.
Dental · 72d
Cleared May 09, 1996
UNIVERSAL DRAINAGE TRAY
K961442 · FCM
Customed, Inc.
Gastroenterology & Urology · 24d
Cleared May 08, 1996
M.I.C.
K950967 · JOW
V.V.T. Healthcare Technologies, Inc.
Cardiovascular · 447d
Cleared May 08, 1996
MINIGUARD
K954215 · MNG
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 243d
Cleared May 08, 1996
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
K954830 · LKP
Orgentec
Immunology · 201d
Cleared May 08, 1996
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
K954831 · LKO
Orgentec
Immunology · 201d
Cleared May 08, 1996
CORDIS BILIARY STENT
K955728 · FGE
Cordis Corp.
Gastroenterology & Urology · 142d
Cleared May 08, 1996
BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE
K960556 · EIA
Scitech Solutions, Inc.
Dental · 89d
Cleared May 08, 1996
ADVANCE TIBIAL COMPONENT
K960617 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared May 08, 1996
HEMISPHERE ACETABULAR CUP
K960660 · LPH
Ortho Development Corp.
Orthopedic · 82d
Cleared May 08, 1996
TITANIUM TUBE TO TUBE CLAMP
K960782 · JEC
Synthes (Usa)
Orthopedic · 72d
Cleared May 08, 1996
FIVE STAR BRONCHOSCOPE
K960876 · EOB
Five Star Medical, Inc.
Ear, Nose, Throat · 65d