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
114385–114408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1993
SYMBIOSIS BONE MARROW BIOPSY NEEDLE
K925416 · GAA
Symbiosis Corp.
General & Plastic Surgery · 119d
Cleared Feb 23, 1993
SKINTEMP, MODIFICATION
K925545 · KGN
Biocore
General & Plastic Surgery · 131d
Cleared Feb 23, 1993
MAGNETIC RETRIEVER
K925565 · GCJ
Cook Urological, Inc.
General & Plastic Surgery · 112d
Cleared Feb 23, 1993
HI CHEM ELECTROLYTE REFERENCE REAGENT
K925611 · JGS
Hichem Diagnostics
Chemistry · 110d
Cleared Feb 23, 1993
DEVMED LENS WASH SHEATH
K925669 · GCJ
Devmed Corp.
General & Plastic Surgery · 105d
Cleared Feb 23, 1993
ACCESSORY TO PISTON SYRINGE
K926007 · FMF
Martech Medical Products, Inc.
General Hospital · 88d
Cleared Feb 23, 1993
THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME
K930274 · JZO
Joldon Diagnostics
Immunology · 35d
Cleared Feb 22, 1993
MAT MEMBRANE AUTOTRANSFUSION SYSTEM
K915130 · CAC
Estracorporeal, Inc.
Anesthesiology · 467d
Cleared Feb 22, 1993
CAVERNOSOMETRY MODULE FOR MENUET
K923117 · DXT
Dantec Medical, Inc.
Gastroenterology & Urology · 241d
Cleared Feb 22, 1993
FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT
K924654 · BXB
Sutter Corp.
Physical Medicine · 160d
Cleared Feb 22, 1993
COMPRESSAR UNIVERSAL (TM) SYSTEM
K925809 · DXC
Instromedix, Inc.
Cardiovascular · 97d
Cleared Feb 22, 1993
EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH
K926450 · DQE
Baxter Healthcare Corp
Cardiovascular · 60d
Cleared Feb 19, 1993
COMFORT PERSONAL LUBRICANT
K915574 · KMJ
Hyman, Phelps & McNamara, P.C.
General Hospital · 435d
Cleared Feb 19, 1993
BIRD GRAPHICS MONITOR
K920113 · CBK
Bird Products Corp.
Anesthesiology · 406d
Cleared Feb 19, 1993
KOLD WRAP STERILE BURN DRESSING
K920554 · MGQ
Kold Products
General & Plastic Surgery · 379d
Cleared Feb 19, 1993
OB/GYN DRAPE
K920808 · KKX
Preferred Medical Products
General Hospital · 364d
Cleared Feb 19, 1993
FLEXIBLE FIBER OPTIC ENDOSCOPE
K922826 · FGA
Optimed Technologies, Inc.
Gastroenterology & Urology · 253d
Cleared Feb 19, 1993
AUTOMATIC TYMPANOMETER
K923073 · ETY
Life-Tech Intl., Inc.
Ear, Nose, Throat · 239d
Cleared Feb 19, 1993
DISPOSABLE NEUROVIEW ENDOSCOPE
K923479 · GWG
Neuro Navigational Corp.
Neurology · 219d
Cleared Feb 19, 1993
JACK'S VENT TUBES
K923887 · ETD
O.R. Specialties, Inc.
Ear, Nose, Throat · 199d
Cleared Feb 19, 1993
UNSCENTED MENSTRUAL TAMPON
K923985 · HEB
Personal Products Co.
Obstetrics & Gynecology · 196d
Cleared Feb 19, 1993
BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY
K924445 · IXY
Control-X, Inc.
Radiology · 171d
Cleared Feb 19, 1993
DISPOSABLE BIOPSY FORCEP
K925881 · GWG
Neuro Navigational Corp.
Neurology · 92d
Cleared Feb 19, 1993
ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR
K926250 · DTN
Electromedics, Inc.
Cardiovascular · 67d