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
91945–91968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1997
ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES
K972008 · GEI
European Surgical, Inc.
General & Plastic Surgery · 112d
Cleared Sep 19, 1997
PULSEMASTER 1000 ST DENTAL LASER SYSTEM
K972325 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 88d
Cleared Sep 19, 1997
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER
K972347 · GEX
Lumenis, Inc.
General & Plastic Surgery · 87d
Cleared Sep 19, 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
K972393 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Sep 19, 1997
IMPERVIOUS ISOLATION GOWN
K972410 · FYC
Kentron Health Care, Inc.
General Hospital · 85d
Cleared Sep 19, 1997
MINISITE*BIPOLAR FORCEPS** DEVICE
K972415 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 84d
Cleared Sep 19, 1997
LYOCELL WOUND DRESSING/SURGICAL SPONGE
K972458 · MGP
Courtaulds Fibers, Inc.
General & Plastic Surgery · 80d
Cleared Sep 19, 1997
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K972568 · MNH
Depuy, Inc.
Orthopedic · 71d
Cleared Sep 19, 1997
ACUFEX SCREW CANNULA
K972599 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 67d
Cleared Sep 19, 1997
IN-SLING
K972651 · OTN
Influence, Inc.
Gastroenterology & Urology · 67d
Cleared Sep 19, 1997
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K972679 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 65d
Cleared Sep 19, 1997
MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL
K972692 · HSB
Zimmer, Inc.
Orthopedic · 64d
Cleared Sep 19, 1997
OT-1
K972781 · FED
Prism Therapeutics, LLC
Gastroenterology & Urology · 56d
Cleared Sep 19, 1997
CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K972785 · LYY
Ansell Perry
General Hospital · 56d
Cleared Sep 19, 1997
AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD
K972901 · GEI
American Biosurgical, Inc.
General & Plastic Surgery · 44d
Cleared Sep 19, 1997
LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION...
K972958 · GCJ
Lysonix, Inc.
General & Plastic Surgery · 39d
Cleared Sep 19, 1997
SILICONE BILIARY STENT/BILIARY CATHETER
K973114 · FGE
Specialty Surgical Products, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 18, 1997
SEAGER ELECTROEJACULATOR
K962379 · LNL
National Rehab Hospital
Gastroenterology & Urology · 455d
Cleared Sep 18, 1997
ONE-WAY VALVE (WITH CONNECTOR)
K970780 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 198d
Cleared Sep 18, 1997
LUXMATIC 12-15 ISC PORTABLE ELECTRIC BREAST PUMP
K971543 · HGX
Kaweco GmbH
Obstetrics & Gynecology · 143d
Cleared Sep 18, 1997
MODEL 20 BIPOLAR COAGULATOR
K972311 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Sep 18, 1997
MONTGOMERY THYROPLASTY IMPLANT SYSTEM
K972317 · MIX
Boston Medical Products, Inc.
Ear, Nose, Throat · 90d
Cleared Sep 18, 1997
SILENTNITE
K972424 · LRK
Glidewell Laboratories
Dental · 83d
Cleared Sep 18, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
K972493 · FPA
Nipro Medical Corp.
General Hospital · 77d