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

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175,820 results
106537–106560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 1994
FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
K925610 · FWP
Microtek Medical, Inc.
General & Plastic Surgery · 743d
Cleared Nov 18, 1994
ZEST IMPLANT ANCHOR
K925849 · DZE
Zest Anchors, Inc.
Dental · 730d
Cleared Nov 18, 1994
SEE-THRU SELF SEALING STERILIZATION POUCH
K940807 · KCT
Asep-Pro, Inc.
General Hospital · 269d
Cleared Nov 18, 1994
PA300
K942512 · FRF
The Rival Co.
General Hospital · 176d
Cleared Nov 18, 1994
OTOVIEW TELESCOPIC OTOSCOPES
K943721 · ERA
Smith & Nephew, Inc.
Ear, Nose, Throat · 109d
Cleared Nov 18, 1994
PARI BABY
K944152 · CAF
Pari Holding Co.
Anesthesiology · 88d
Cleared Nov 18, 1994
ACRA-CUT
K944311 · HBO
Acra Cut, Inc.
Neurology · 77d
Cleared Nov 18, 1994
PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING
K944429 · CAI
Precision Thermoplastic Components, Inc.
Anesthesiology · 67d
Cleared Nov 18, 1994
APEX UNIVERSAL DRIVE SYSTEM
K944476 · ERL
Linvatec Corp.
Ear, Nose, Throat · 67d
Cleared Nov 18, 1994
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K944651 · JWY
Baxter Diagnostics, Inc.
Microbiology · 53d
Cleared Nov 18, 1994
CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING
K945314 · CAI
Cleveland Tubing, Inc.
Anesthesiology · 17d
Cleared Nov 17, 1994
THE PERMARIDGE MATRIX CHIN
K931500 · FWP
Applied Biomaterial Technologies
General & Plastic Surgery · 602d
Cleared Nov 17, 1994
AUTOPAK INSTRUMENT TRAY STERILIZATION POUCH
K932086 · KCT
Ongard Meddevice Packaging, Inc.
General Hospital · 566d
Cleared Nov 17, 1994
AUTOPAK STERILIZATION POUCH
K932088 · KCT
Ongard Meddevice Packaging, Inc.
General Hospital · 566d
Cleared Nov 17, 1994
PROSPECT CRYPTOSPORIDIUM RAPID ASSAY
K936191 · MHJ
Alexon Biomedical, Inc.
Microbiology · 329d
Cleared Nov 17, 1994
ANNELID
K940886 · JCX
Kinetic Concepts, Inc.
General & Plastic Surgery · 265d
Cleared Nov 17, 1994
SMOOTH FIT
K941575 · DZE
Hi-Tec Implants
Dental · 231d
Cleared Nov 17, 1994
SENSATEC ENDOSCOPIC INSTRUMENTS
K942080 · GEI
Linvatec Corp.
General & Plastic Surgery · 202d
Cleared Nov 17, 1994
ENVISION ARTHROSCOPE, CANNULA,TROCAR, OBTURATOR, AND PROBE
K942427 · HRX
Envision Surgical System, Inc.
Orthopedic · 181d
Cleared Nov 17, 1994
DISPOSABLE BIPOLAR COAGULATING FORCEPS
K942710 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 161d
Cleared Nov 17, 1994
ECONOSTAND
K943129 · IPL
Sf Research Corp.
Physical Medicine · 141d
Cleared Nov 17, 1994
INSUFFLATOR TUBING WITH FILTER
K943508 · HET
Stryker Endoscopy
Obstetrics & Gynecology · 120d
Cleared Nov 17, 1994
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
K943550 · LCQ
Sigma Diagnostics, Inc.
Toxicology · 119d
Cleared Nov 17, 1994
HERCULITE XR & XRV
K943642 · EBF
Sybron Dental Specialties, Inc.
Dental · 113d