FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,107 results for "smith"
385–408 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jul 02, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K091627 · KCT
Smith & Nephew, Inc.
General Hospital · 29d
Cleared Jul 01, 2009
ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
K081923 · ONT
Glaxosmithkline Consumer Healthcare
General Hospital · 359d
Cleared Jun 26, 2009
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
K083119 · BTR
Smiths Medical Asd, Inc.
Anesthesiology · 247d
Cleared Jun 12, 2009
LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS
K091181 · MRZ
Smiths Medical MD, Inc.
General Hospital · 50d
Cleared Jun 08, 2009
SMITH & NEPHEW RAIL SYSTEM
K090926 · KTT
Smith & Nephew, Inc.
Orthopedic · 67d
Cleared Jun 04, 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675 · HRS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Jun 03, 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656 · HWC
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Jun 03, 2009
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL...
K083336 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 203d
Cleared May 27, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
K090420 · OLO
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared May 01, 2009
PORTEX TUOHY EPIDURAL NEEDLE 17G, PORTEX TUOHY EPIDURAL NEEDLE 18G
K090261 · BSP
Smiths Medical Asd, Inc.
Anesthesiology · 87d
Cleared May 01, 2009
BCI WW1030 PULSE OXIMETER
K083557 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 150d
Cleared Apr 28, 2009
BCI WW1021 PC APPLICATION
K090205 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 90d
Cleared Apr 15, 2009
BCI WW1000 PULSE OXIMETER, MODEL WW1000
K083787 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 117d
Cleared Apr 09, 2009
BCI WW1020 PULSE OXIMETER, MODEL WW1020
K083705 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 115d
Cleared Apr 01, 2009
SPINESMITH CYNCH SPINAL SYSTEM
K090376 · MAX
Spine Smith Partners L.P.
Orthopedic · 43d
Cleared Mar 18, 2009
SMITH & NEPHEW INSTRUMENT TRAYS
K090562 · KCT
Smith & Nephew, Inc.
General Hospital · 16d
Cleared Mar 11, 2009
PIGALILEO TKR BASE V2.3 AND CAS V4.1
K090313 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 11, 2009
BIOLOX DELTA CERAMIC FEMORAL HEADS
K083762 · LZO
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Mar 04, 2009
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
K083451 · BSN
Smiths Medical Asd, Inc.
Anesthesiology · 103d
Cleared Mar 03, 2009
R3 CONSTRAINED LINER, CONSTRAINED LINER
K083566 · KWZ
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 103d
Cleared Feb 23, 2009
BIVONA TRACHEOSTOMY TUBES
K083641 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 76d
Cleared Feb 20, 2009
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
K083565 · HAW
Smith & Nephew, Inc.
Neurology · 79d
Cleared Feb 09, 2009
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
K082371 · LZO
Smith & Nephew, Inc.
Orthopedic · 175d