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
100705–100728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 29, 1995
TOWEL PACK
K952759 · KKX
Medcare Custom Packaging, Inc.
General Hospital · 105d
Cleared Sep 29, 1995
INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL
K952923 · HSB
Howmedica Corp.
Orthopedic · 95d
Cleared Sep 29, 1995
THE TULIP SMALL SOFT TISSUE RETRACTOR
K952935 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 95d
Cleared Sep 29, 1995
THE TULIP LARGE SOFT TISSUE RETRACTOR
K952980 · GCJ
The Tulip Mfg. Co.
General & Plastic Surgery · 95d
Cleared Sep 29, 1995
SPIN ROLLERE
K952990 · ISA
Kinsei Shiatsu, Inc.
Physical Medicine · 93d
Cleared Sep 29, 1995
MICROSURGE THORACOSCOPIC ACCESS SYSTEM
K953121 · GCJ
Microsurge, Inc.
General & Plastic Surgery · 86d
Cleared Sep 29, 1995
ABBOTT VISION HEMOGLOBIN (MODIFICATION)
K953221 · KHG
Abbott Laboratories
Hematology · 102d
Cleared Sep 29, 1995
EXSPOR
K953241 · LRJ
Alcide Corp.
Gastroenterology & Urology · 80d
Cleared Sep 29, 1995
OCTOROLL
K953246 · KXH
Octostop, Inc.
Radiology · 80d
Cleared Sep 29, 1995
BIOPLATE RIGID FIXATION BONE PLATING SYSTEM
K953273 · JEY
Biomedics
Dental · 78d
Cleared Sep 29, 1995
BRIMFIELD PRECISION ARTICULATING FAN RETRACTOR
K953410 · GCJ
Springfield Surgical Instruments
General & Plastic Surgery · 71d
Cleared Sep 29, 1995
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
K953417 · DXY
Cook Pacemaker Corp.
Cardiovascular · 113d
Cleared Sep 29, 1995
AESCULAP BIPOLAR CORDS
K953446 · GEI
Aesculap, Inc.
General & Plastic Surgery · 74d
Cleared Sep 29, 1995
COMFEEL:ALGINATE DRESSING
K953497 · KMF
Coloplast A/S
General & Plastic Surgery · 65d
Cleared Sep 29, 1995
NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER
K953574 · HET
American Hydro-Surgical Instruments,...
Obstetrics & Gynecology · 60d
Cleared Sep 29, 1995
PROPHY ANGLE
K953628 · EHK
Rolence Enterprise Co. , Ltd.
Dental · 60d
Cleared Sep 29, 1995
ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODIFICATION)
K953659 · HRX
Arthrocare Corp.
Orthopedic · 58d
Cleared Sep 29, 1995
GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH
K953868 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 43d
Cleared Sep 29, 1995
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
K953953 · KCY
Deroyal Industries, Inc.
General & Plastic Surgery · 38d
Cleared Sep 29, 1995
UNIVERSAL PLUS ES S/I INSTRUMENT
K954056 · GEI
Conmedcorp
General & Plastic Surgery · 31d
Cleared Sep 29, 1995
TITAN 20 CC DRIVER
K954059 · MEB
I-Flow Corp.
General Hospital · 31d
Cleared Sep 29, 1995
VOXCAM
K954198 · LMC
Voxel
Radiology · 23d
Cleared Sep 29, 1995
VOXBOX
K954199 · IXC
Voxel
Radiology · 23d
Cleared Sep 29, 1995
VOXGRAM
K954200 · IWZ
Voxel
Radiology · 23d