FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124057–124080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 1990
EMIT (R) II PHENCYCLIDINE ASSAY
K904765 · LCM
Syva Co.
Toxicology · 37d
Cleared Nov 28, 1990
TORQUE FRAME QTF1000
K904898 · IKK
Medmetric Corp.
Physical Medicine · 29d
Cleared Nov 28, 1990
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE
K904995 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 21d
Cleared Nov 28, 1990
EZ-SCREEN:BARBITURATES
K905057 · DIS
Environmental Diagnostics, Inc.
Toxicology · 20d
Cleared Nov 28, 1990
GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138
K905096 · JQB
Amresco, Inc.
Chemistry · 15d
Cleared Nov 27, 1990
MOTO-MED RF-II AND PICO
K893924 · BXB
Holl Meditronics, Inc.
Physical Medicine · 545d
Cleared Nov 27, 1990
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579 · KNT
Abbott Laboratories
Gastroenterology & Urology · 111d
Cleared Nov 27, 1990
SINGLE LUMEN CATHETERS, MODIFICATION
K904140 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 82d
Cleared Nov 27, 1990
ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS
K904156 · LZV
Origin Medsystems, Inc.
Orthopedic · 81d
Cleared Nov 27, 1990
RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
K904210 · LIF
Minntech Corp.
Gastroenterology & Urology · 76d
Cleared Nov 27, 1990
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
K904299 · FGD
E-Z-Em, Inc.
Gastroenterology & Urology · 69d
Cleared Nov 27, 1990
UROLAB JANUS
K904386 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 64d
Cleared Nov 27, 1990
CARESS MASSAGER
K904915 · ISA
Kendex Corp.
Physical Medicine · 27d
Cleared Nov 27, 1990
BIO MEDX AIR FLOTATION SYSTEM
K905156 · IOQ
Bio Clinic Co.
Physical Medicine · 12d
Cleared Nov 26, 1990
MENTOR TISSUE EXPANDERS W/TDMAC COATING
K894475 · LCJ
Mentor Corp.
General & Plastic Surgery · 496d
Cleared Nov 26, 1990
ACE/WILLIAMS MICROSURGERY SAW SYSTEM
K902525 · HWE
Buckman Co., Inc.
Orthopedic · 174d
Cleared Nov 26, 1990
COLOR VELOCITY IMAGING (CVI) OPTION FOR PLATINUM
K902926 · ITX
Philips Medical Systems North...
Radiology · 146d
Cleared Nov 26, 1990
A-1103 ABUTMENT (REMOVABLE)
K903040 · DZE
Minimatic Implant Technology
Dental · 138d
Cleared Nov 26, 1990
MUSCLE MASSAGER
K903617 · ISA
Uri Halfon and Gabriel Hertzberg
Physical Medicine · 110d
Cleared Nov 26, 1990
VSP HIP STEM
K903957 · JDI
Turnkey Intergration USA, Inc.
Orthopedic · 90d
Cleared Nov 26, 1990
CUI FEATHERED SILICONE MALAR
K904348 · LZK
Cui Corp.
General & Plastic Surgery · 63d
Cleared Nov 26, 1990
CUI CURVILINEAR SILICONE CHIN
K904349 · FWP
Cui Corp.
General & Plastic Surgery · 63d
Cleared Nov 26, 1990
CUI DORSAL COLUMELLA PROSTHESIS
K904350 · FZE
Cui Corp.
General & Plastic Surgery · 63d
Cleared Nov 26, 1990
KIMONO PLUS
K904375 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 62d