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
113713–113736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 1993
AVI MODEL 3100 INFUSION PUMP
K923068 · FRN
3M Health Care, Ltd.
General Hospital · 299d
Cleared Apr 20, 1993
INGROWN TOENAIL PAD
K923662 · KGX
Many Bee Co.
General & Plastic Surgery · 272d
Cleared Apr 20, 1993
GILLAM-TUKEL BONE MARROW BIOPSY NEEDLE
K924501 · GAA
Symbiosis Corp.
General & Plastic Surgery · 228d
Cleared Apr 20, 1993
STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD
K924761 · GCJ
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 209d
Cleared Apr 20, 1993
ALLKARE(TM) ADHESIVE REMOVER WIPE
K924976 · KOX
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 201d
Cleared Apr 20, 1993
PLEUR-EVAC CARDIOTOMY RESERVOIR
K925046 · DTN
Deknatel, Inc.
Cardiovascular · 196d
Cleared Apr 20, 1993
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806
K925550 · CDS
Hichem Diagnostics
Chemistry · 168d
Cleared Apr 20, 1993
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
K925551 · CGA
Hichem Diagnostics
Chemistry · 168d
Cleared Apr 20, 1993
HI CHEM ELECTROLYTE BUFFER
K925612 · JGS
Hichem Diagnostics
Chemistry · 166d
Cleared Apr 20, 1993
KTI TRANSPARENT WOUND DRESSING
K925660 · MGP
Kingston Technologies, Inc.
General & Plastic Surgery · 161d
Cleared Apr 20, 1993
OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K925695 · LZO
Osteonics Corp.
Orthopedic · 159d
Cleared Apr 20, 1993
DISPOSABLE ELECTROSURGERY BALL ELECTRODE
K925708 · DWG
Beacon Laboratories, Inc.
General & Plastic Surgery · 159d
Cleared Apr 20, 1993
BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS
K925779 · NHA
Nobelpharma USA, Inc.
Dental · 155d
Cleared Apr 20, 1993
HEAD & FOOT END DROP PEDI-CRIB
K925817 · FMS
Pedicraft, Inc.
General Hospital · 154d
Cleared Apr 20, 1993
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
K925842 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 153d
Cleared Apr 20, 1993
PEDICRAGT BASSINET
K925949 · FMS
Pedicraft, Inc.
General Hospital · 147d
Cleared Apr 20, 1993
EPI-LOCK WOUND DRESSING
K926034 · MGP
Calgon Vestal Div.
General & Plastic Surgery · 140d
Cleared Apr 20, 1993
UNICLIP SURGICAL CLIP APPLIER
K926199 · GDO
Unisurge, Inc.
General & Plastic Surgery · 132d
Cleared Apr 20, 1993
ENDOSCOPE AND ACCESSORIES
K926223 · GCJ
Weck Endoscopy
General & Plastic Surgery · 131d
Cleared Apr 20, 1993
MEDICOTEST SKIN FIX
K926264 · KGX
Medicotest, Inc.
General & Plastic Surgery · 123d
Cleared Apr 20, 1993
BURN SHEET
K926290 · FPY
Gam Industries, Inc.
General & Plastic Surgery · 127d
Cleared Apr 20, 1993
KWIK BOARD
K930197 · KMK
Astral, Ltd.
General Hospital · 96d
Cleared Apr 20, 1993
CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO
K930208 · DLI
Heraeus Kulzer, Inc.
Toxicology · 95d
Cleared Apr 20, 1993
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K930241 · KNW
Olympus Corp.
Gastroenterology & Urology · 91d