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

1,136 results for "smith"
457–480 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jul 24, 2008
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
K081351 · HSX
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 23, 2008
LEGION HINGE KNEE SYSTEM
K081111 · KRO
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Jul 21, 2008
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G,...
K081229 · JKA
Smiths Medical Asd, Inc.
Chemistry · 82d
Cleared Jul 18, 2008
CADD MEDICATION CASSETTE RESERVOIR
K081156 · FPA
Smiths Medical MD, Inc.
General Hospital · 86d
Cleared Jul 18, 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · HAW
Smith & Nephew, Inc.
Neurology · 109d
Cleared Jul 16, 2008
ENDOBUTTON CONTINUOUS LOOP (CL)
K081098 · JDR
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 90d
Cleared Jul 14, 2008
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
K081132 · KWQ
Spine Smith Partners L.P.
Orthopedic · 84d
Cleared Jul 02, 2008
SPINESMITH CIMPLICITY SPINAL SYSTEM
K080971 · MQP
Spine Smith Partners L.P.
Orthopedic · 89d
Cleared Jun 19, 2008
SMITH & NEPHEW CDS SYSTEM
K081491 · JAA
Smith & Nephew, Inc.
Radiology · 22d
Cleared Jun 18, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING...
K081106 · HRS
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Jun 09, 2008
SL-PLUS STANDARD AND LATERAL HIP STEMS
K072852 · LZO
Smith & Nephew, Inc.
Orthopedic · 249d
Cleared Jun 02, 2008
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION...
K072080 · LGZ
Smiths Medical Asd, Inc.
General Hospital · 308d
Cleared May 21, 2008
SMITH & NEPHEW INSTRUMENT TRAYS
K073551 · KCT
Smith & Nephew Inc., Endoscopy Div.
General Hospital · 155d
Cleared May 15, 2008
ECHELON TITANIUM HIP SYSTEM
K072817 · LPH
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared May 08, 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625 · LPH
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared Apr 25, 2008
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP
K080743 · FRN
Smiths Medical MD, Inc.
General Hospital · 39d
Cleared Apr 23, 2008
PLLA, HA SCREW
K080358 · HWC
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 72d
Cleared Apr 10, 2008
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434 · JDO
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Mar 07, 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
K072212 · KTT
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Mar 07, 2008
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY...
K072144 · MEA
Smiths Medical MD, Inc.
General Hospital · 218d
Cleared Mar 04, 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · HWC
Smith & Nephew, Inc.
Orthopedic · 82d
Cleared Feb 22, 2008
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
K073466 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 74d
Cleared Feb 13, 2008
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF...
K072955 · MRZ
Smiths Medical MD, Inc.
General Hospital · 117d
Cleared Feb 08, 2008
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
K073188 · FMI
Smiths Medical Asd, Inc.
General Hospital · 87d