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"
409–432 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jan 30, 2009
SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW
K083635 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 53d
Cleared Jan 30, 2009
SMITH & NEPHEW PEEK INTERFERENCE SCREW
K083226 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 88d
Cleared Jan 28, 2009
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
K083528 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 61d
Cleared Jan 07, 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032 · HRS
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Dec 17, 2008
CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
K082783 · MRZ
Smiths Medical MD, Inc.
General Hospital · 85d
Cleared Nov 25, 2008
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
K082358 · JWH
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared Nov 14, 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 100d
Cleared Nov 03, 2008
OSTEORAPTOR SUTURE ANCHOR
K082215 · JDR
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 89d
Cleared Oct 31, 2008
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
K082821 · KWQ
Spine Smith Partners L.P.
Orthopedic · 36d
Cleared Oct 29, 2008
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
K082267 · HAW
Smith & Nephew, Inc.
Neurology · 79d
Cleared Oct 21, 2008
ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
K082095 · HTN
Smith & Nephew Endoscopy, Inc.
Orthopedic · 89d
Cleared Sep 17, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · HWC
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Sep 12, 2008
BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
K081440 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 113d
Cleared Sep 05, 2008
RENASYS EZ
K082426 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 14d
Cleared Sep 05, 2008
SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
K081016 · PHX
Smith & Nephew, Inc.
Orthopedic · 149d
Cleared Aug 26, 2008
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
K081511 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 21, 2008
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566 · LPH
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Aug 13, 2008
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND...
K081086 · BTR
Smiths Medical Asd, Inc.
Anesthesiology · 119d
Cleared Jul 31, 2008
MDF REVISION HIP SYSTEM
K081124 · MEH
Smith & Nephew, Inc.
Orthopedic · 101d
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