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
84193–84216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1999
NRC NON-RINSE CONDITIONER
K992519 · EBC
Dentsply Intl.
Dental · 86d
Cleared Oct 22, 1999
D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
K992629 · LBH
Centrix, Inc.
Dental · 86d
Cleared Oct 22, 1999
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
K993181 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 22, 1999
DRYASOL ACID CONCENTRATE MIX
K993212 · KPO
Diasol, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 22, 1999
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
K993220 · BYJ
Puritan Bennett Corp.
Anesthesiology · 25d
Cleared Oct 22, 1999
SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600
K993265 · GEI
Soring GmbH Medizintechnik
General & Plastic Surgery · 23d
Cleared Oct 21, 1999
ZOLL M SERIES 12SL ANALYSIS OPTION
K991556 · MKJ
Zoll Medical Corp
Cardiovascular · 170d
Cleared Oct 21, 1999
CATHETER INNOVATIONS IMPLANTABLE PORT
K991897 · LJT
Catheter Innovations, Inc.
General Hospital · 139d
Cleared Oct 21, 1999
PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
K992582 · EKL
Pacific Implant, Inc.
Dental · 80d
Cleared Oct 21, 1999
SURGEON POWDER-FREE GLOVES, LATEX, STERILE
K992679 · KGO
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 72d
Cleared Oct 21, 1999
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
K992898 · GZT
Bright Medical Instruments
Neurology · 55d
Cleared Oct 21, 1999
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
K992899 · KWS
Biomet, Inc.
Orthopedic · 52d
Cleared Oct 21, 1999
JEL BIOS 10 (CODE NAME RD-1801)
K993136 · EJT
J.F. Jelenko & Co., Inc.
Dental · 31d
Cleared Oct 21, 1999
MEDTRONIC AVE BRIDGE STENT
K993145 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 21, 1999
JEL BIOS 18 (CODE NAME RD- 1214)
K993152 · EJT
J.F. Jelenko & Co., Inc.
Dental · 30d
Cleared Oct 21, 1999
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
K993171 · DSI
Hewlett-Packard Co.
Cardiovascular · 30d
Cleared Oct 21, 1999
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC...
K993257 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Oct 20, 1999
TRIO 300
K990787 · IPF
Ito Co., Ltd.
Physical Medicine · 224d
Cleared Oct 20, 1999
CASE 8000 EXERCISE TESTING SYSTEM
K991014 · LOS
General Electric Medical Systems...
Cardiovascular · 208d
Cleared Oct 20, 1999
ACTIVA
K991132 · INI
Hoveround Corp.
Physical Medicine · 201d
Cleared Oct 20, 1999
125 IMPLANT SEEDS, MODEL STM1251
K991280 · KXK
Sourcetech Medical, LLC
Radiology · 189d
Cleared Oct 20, 1999
50 W METAL HALIDE ILLUMINATOR, VES 0501.
K992447 · FCW
Angiolaz, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 20, 1999
BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
K992468 · FLL
Braun GmbH
General Hospital · 89d
Cleared Oct 20, 1999
AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING...
K993080 · LYY
Medtexx Partners, Inc.
General Hospital · 36d