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
117985–118008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1992
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG
K912966 · LDD
Physio-Control Corp.
Cardiovascular · 228d
Cleared Feb 21, 1992
MULTILASE 2100 A
K913290 · GEX
Teknomed, Inc.
General & Plastic Surgery · 212d
Cleared Feb 21, 1992
STORZ MICRO CUTTER 25 GAUGE PACK
K913504 · HQE
Storz
Ophthalmic · 198d
Cleared Feb 21, 1992
SURGICAL ELECTRICAL PENCIL
K913623 · GEI
Aaron Medical, Inc.
General & Plastic Surgery · 192d
Cleared Feb 21, 1992
VENTREX ALLERGEN DISC
K913833 · DHB
Ventrex Laboratories, Inc.
Immunology · 179d
Cleared Feb 21, 1992
URIC ACID REAGENT SET
K914158 · KNK
Tech Intl. Co.
Chemistry · 157d
Cleared Feb 21, 1992
SILVER FOAM WOUND DRESSING
K914579 · FRO
Vitaphore Corp.
General & Plastic Surgery · 128d
Cleared Feb 21, 1992
CAPIOX LEVEL ALARM
K915337 · DTW
Terumo Medical Corp.
Cardiovascular · 87d
Cleared Feb 21, 1992
OPACITRAC
K915356 · HJO
Oculon Corp.
Ophthalmic · 87d
Cleared Feb 21, 1992
RSP MEGA SAMPLE PROCESSOR
K915492 · JQW
Tecan U.S., Ltd.
Chemistry · 79d
Cleared Feb 21, 1992
USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
K915553 · DYB
C.R. Bard, Inc.
Cardiovascular · 72d
Cleared Feb 21, 1992
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · LYR
Quidel Corp.
Microbiology · 56d
Cleared Feb 21, 1992
XENON ARC ENDOSCOPE LIGHT SOURCE
K920403 · GCJ
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 21d
Cleared Feb 20, 1992
SKYTRON INFINITY SERIES SURGICAL LIGHTS
K915285 · FSY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 87d
Cleared Feb 20, 1992
FOIL BABY BUNTING
K915303 · KME
Gam Industries, Inc.
General Hospital · 91d
Cleared Feb 20, 1992
AAP BONE PLATE
K915315 · HRS
Aap International, Ltd.
Orthopedic · 90d
Cleared Feb 19, 1992
ETEX DENTAL IMPLANT SYSTEM
K913417 · DZE
Etex Co.
Dental · 203d
Cleared Feb 19, 1992
CORDIS RIGHT-ANGLE CATHETER GUIDE
K913842 · JXG
Cordis Corp.
Neurology · 175d
Cleared Feb 19, 1992
OPTICAL FRAMES & SUNGLASSES
K914310 · HQY
Societe Nouvelle Idc
Ophthalmic · 147d
Cleared Feb 19, 1992
URESIL FIXATION DEVICE
K914699 · FGE
Uresil Corp.
Gastroenterology & Urology · 124d
Cleared Feb 19, 1992
AM 300 AGC-O
K914948 · ESD
Electone, Inc.
Ear, Nose, Throat · 107d
Cleared Feb 19, 1992
IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
K914953 · LKI
Stellar Bio Systems, Inc.
Microbiology · 106d
Cleared Feb 19, 1992
PROFLEX 5
K915168 · LIT
Peripheral Systems Group
Cardiovascular · 96d
Cleared Feb 19, 1992
TRAC-WRIGHT TRAC 10 CATHETER
K915238 · MCW
Dow Corning Wright
Cardiovascular · 90d