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
84961–84984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1999
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA,...
K991623 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 90d
Cleared Aug 09, 1999
MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
K991628 · GEX
Esc Medical Systems, Inc.
General & Plastic Surgery · 90d
Cleared Aug 09, 1999
KRONUS OPTIQUANT THYROGLOBULIN KIT
K991720 · MSW
Unchanged
Immunology · 81d
Cleared Aug 09, 1999
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
K991890 · MVJ
Cogent Diagnotics , Ltd.
Immunology · 67d
Cleared Aug 09, 1999
3M LVR SYSTEM
K991961 · EBF
3M Company
Dental · 60d
Cleared Aug 09, 1999
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
K992138 · ETA
Micromedics, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 09, 1999
ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
K992428 · LYY
Tillotson Healthcare Corp.
General Hospital · 19d
Cleared Aug 06, 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA)...
K990666 · MEH
Smith & Nephew, Inc.
Orthopedic · 157d
Cleared Aug 06, 1999
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
K991284 · MXK
Nidek, Inc.
Ophthalmic · 113d
Cleared Aug 06, 1999
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
K991715 · MAI
Linvatec Corp.
Orthopedic · 78d
Cleared Aug 06, 1999
SALTER LABS PEP DEVICE
K991788 · CAF
Salter Labs
Anesthesiology · 73d
Cleared Aug 06, 1999
ULTIMAX ANKLE FUSION ROD SYSTEM
K991790 · HSB
Encore Orthopedics, Inc.
Orthopedic · 72d
Cleared Aug 06, 1999
VHS SUPRACONDYLAR PLATE SYSTEM
K991806 · KTT
Walter Abendschein, M.D.
Orthopedic · 72d
Cleared Aug 06, 1999
MACMED PAEDIATRIC INTRAMEDULLARY NAIL
K991877 · JDS
Innervision, Inc.
Orthopedic · 65d
Cleared Aug 06, 1999
FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
K992040 · HRX
Fiber Imaging Technologies, Inc.
Orthopedic · 50d
Cleared Aug 06, 1999
MXU-125 OR TMX-125
K992229 · IZL
Trex Medical Corp.
Radiology · 35d
Cleared Aug 06, 1999
H20- TETHERED OPTION
K992291 · OLV
Grass-Telefactor Product Group
Neurology · 30d
Cleared Aug 06, 1999
VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
K992406 · GEI
Mitek Products
General & Plastic Surgery · 17d
Cleared Aug 05, 1999
DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE
K983618 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 294d
Cleared Aug 05, 1999
SILGEL STC-S
K984029 · MDA
Nagor , Ltd.
General & Plastic Surgery · 266d
Cleared Aug 05, 1999
RITEFLO SPACER
K984085 · CAF
Aeromax Technologies, Inc.
Anesthesiology · 262d
Cleared Aug 05, 1999
UROSTYM BIOFEEDBACK AND STIMULATION PROBES
K990041 · KPI
Laborie Medical Tech Corp.
Gastroenterology & Urology · 211d
Cleared Aug 05, 1999
HOFFMAN IVF-1
K991216 · MQG
(Arms) Hoffman Surgical Equipment,...
Obstetrics & Gynecology · 118d
Cleared Aug 05, 1999
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE,...
K991261 · MQH
Research Instruments , Ltd.
Obstetrics & Gynecology · 114d