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
71833–71856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2003
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME...
K030533 · LCX
Cenogenics Corp.
Chemistry · 62d
Cleared Apr 17, 2003
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
K030613 · MHX
Criticare Systems, Inc.
Cardiovascular · 50d
Cleared Apr 17, 2003
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
K030791 · KLW
Tinnitech, Ltd.
Ear, Nose, Throat · 36d
Cleared Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG...
K030855 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Apr 17, 2003
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K030862 · MNI
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Apr 17, 2003
POWDERED VINYL EXAM GLOVES, WHITE
K030927 · LYZ
Copioumed Intl., Inc.
General Hospital · 24d
Cleared Apr 17, 2003
GE LOGIQ 9 MODEL 2375600
K030934 · IYN
Ge Medical Systems, Inc.
Radiology · 23d
Cleared Apr 17, 2003
INFINTT CO., LTD. STARPACS SYSTEM
K031013 · LLZ
Infinitt Company
Radiology · 17d
Cleared Apr 16, 2003
PANCREATIC DRAINAGE TUBE
K021672 · FGE
Aomori Olympus Co., Ltd.
Gastroenterology & Urology · 330d
Cleared Apr 16, 2003
A/T X-RAY 70
K024285 · EHD
Air Techniques, Inc.
Radiology · 114d
Cleared Apr 16, 2003
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
K030165 · LHQ
Thermatrek
Radiology · 90d
Cleared Apr 16, 2003
IMBIBE II SYRINGE
K030208 · FMF
Orthovita, Inc.
General Hospital · 85d
Cleared Apr 16, 2003
HTS ARRAY COIL
K030540 · MOS
Jockey Club Mri Engineering Center
Radiology · 55d
Cleared Apr 16, 2003
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 16, 2003
ARTHROCARE PERCD SPINEWAND
K030954 · GEI
Arthrocare Corp.
General & Plastic Surgery · 20d
Cleared Apr 15, 2003
DIOLASE 980 D LASER SYSTEM
K023547 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 176d
Cleared Apr 15, 2003
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
K030147 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 90d
Cleared Apr 15, 2003
GROMAN PREPMASTER
K030292 · KOJ
Groman, Inc.
Dental · 77d
Cleared Apr 15, 2003
IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS...
K030385 · FPA
Kawasumi Laboratories America, Inc.
General Hospital · 69d
Cleared Apr 15, 2003
BIOUNIVERSAL PKF
K030435 · EJT
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Apr 15, 2003
BIO UNIVERSAL
K030436 · EJT
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Apr 14, 2003
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
K023308 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 193d
Cleared Apr 14, 2003
L1 SYSTEM
K024170 · FMK
Pelikan Technologies, Inc.
General & Plastic Surgery · 117d
Cleared Apr 14, 2003
VINCO BRAND ACUPUNCTURE NEEDLE
K024207 · MQX
Helio Medical Supplies, Inc.
General Hospital · 115d