Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
74689–74712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2002
ISO FUNCTIONAL
K022430 · ELW
GC America, Inc.
Dental · 85d
Cleared Oct 18, 2002
NIPRO BIO-FLEX CATHETER
K022756 · FOZ
Nipro Medical Corp.
General Hospital · 59d
Cleared Oct 18, 2002
TRANSCURE, MODEL 2910
K022862 · EBZ
Kinetic Instruments, Inc.
Dental · 51d
Cleared Oct 18, 2002
ELCAM STOPCOCKS AND MANIFOLDS
K022895 · FMG
Medical Device Consultants, Inc.
General Hospital · 45d
Cleared Oct 18, 2002
UNIVERSAL CERAMIC SOLDER
K022969 · EJT
Ivoclar Vivadent, Inc.
Dental · 42d
Cleared Oct 18, 2002
AQUILLA MODULAR WHEELCHAIR
K023005 · IOR
Haywood Vocational Opportunities
Physical Medicine · 39d
Cleared Oct 18, 2002
TIMEX DIGITAL ORAL THERMOMETERS
K023069 · FLL
Medport, Inc.
General Hospital · 32d
Cleared Oct 18, 2002
BD K-4000 MICROKERATOME SYSTEM
K023092 · HMY
Becton, Dickinson & CO
Ophthalmic · 30d
Cleared Oct 18, 2002
AROX 45-JBP
K023099 · DTB
Biotronik, Inc.
Cardiovascular · 30d
Cleared Oct 18, 2002
CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
K023116 · DTK
Cordis Corp.
Cardiovascular · 29d
Cleared Oct 18, 2002
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K023133 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 18, 2002
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204 · MNH
Ebi, L.P.
Orthopedic · 23d
Cleared Oct 18, 2002
MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE
K023235 · LYZ
Shandong Jiazhan Plastic Products...
General Hospital · 21d
Cleared Oct 18, 2002
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
K023249 · NCF
Alcon Laboratories, Inc.
Ophthalmic · 18d
Cleared Oct 18, 2002
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
K023260 · HWC
Osteomed Corp.
Orthopedic · 18d
Cleared Oct 18, 2002
MICROFIX
K023314 · KTT
Fixano SA
Orthopedic · 45d
Cleared Oct 18, 2002
I-FLOW ELASTOMERIC PUMP WITH BOLUS
K023318 · MEB
I-Flow Corp.
General Hospital · 14d
Cleared Oct 18, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K023324 · KTT
Ebi, L.P.
Orthopedic · 14d
Cleared Oct 17, 2002
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816 · FRO
Dynarex Corp.
General & Plastic Surgery · 421d
Cleared Oct 17, 2002
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
K013921 · FAD
Porges S.A.
Gastroenterology & Urology · 324d
Cleared Oct 17, 2002
BIOSTEON CROSS PIN
K021351 · HWC
Biocomposites, Ltd.
Orthopedic · 171d
Cleared Oct 17, 2002
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K021815 · HAW
Smith & Nephew, Inc.
Neurology · 136d
Cleared Oct 17, 2002
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
K021835 · FTL
Brennen Medical, Inc.
General & Plastic Surgery · 135d
Cleared Oct 17, 2002
PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX,...
K021856 · EYB
Porges S.A.
Gastroenterology & Urology · 133d