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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
154609–154632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1983
COMFEEL BARRIER CREAM
K833569 · EXB
Coloplast A/S
Gastroenterology & Urology · 76d
Cleared Dec 27, 1983
PULSATOR ARTERIAL BLOOD SAMPLING SYRIN
K833582 · CBT
Concord Laboratories, Inc.
Anesthesiology · 76d
Cleared Dec 27, 1983
X-BEAM FILM 3TC
K833592
Amorient Ent.
Dental · 76d
Cleared Dec 27, 1983
DERMATEX STERILE FINGER BANDAGE
K833638 · NAD
Dermatec, Inc.
General & Plastic Surgery · 71d
Cleared Dec 27, 1983
ANGIO-SET INTRAVENOUS CATH. SET
K833657 · FOZ
Deseret Medical, Inc.
General Hospital · 70d
Cleared Dec 27, 1983
ARMBOARD AND THE BOARD
K833664 · BTX
Rick Robbin & Frederick Auerbach
General & Plastic Surgery · 70d
Cleared Dec 27, 1983
CHEM KIT THEOPHYLLINE DIAG. KIT
K833683 · KLS
Abbott Laboratories
Toxicology · 57d
Cleared Dec 27, 1983
IVEX-INT
K833684 · FPB
Abbott Laboratories
General Hospital · 57d
Cleared Dec 27, 1983
ACA THYROXINE CALIBRATOR
K833700 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 70d
Cleared Dec 27, 1983
EMIT NETILMICIN ASSAY
K833715 · LCE
Syva Co.
Toxicology · 67d
Cleared Dec 27, 1983
NON - ADHERENT BANDAGE
K833733 · FRO
American Medical Disposable, Inc.
General & Plastic Surgery · 63d
Cleared Dec 27, 1983
LEAP STREP TEST KIT
K833738 · GTP
Cooper Biomedical, Inc.
Immunology · 63d
Cleared Dec 27, 1983
VENOSET MULTI-MED PIGGYBACK W/IVEX-2
K833740 · FPA
Abbott Laboratories
General Hospital · 62d
Cleared Dec 27, 1983
PERITONEAL CATHETER-CHANGES-
K833749 · FKX
Quinton, Inc.
Gastroenterology & Urology · 62d
Cleared Dec 27, 1983
CURITY 100% SILICONE COUDE' CATHETER
K833790 · KOD
The Kendal Co.
Gastroenterology & Urology · 57d
Cleared Dec 27, 1983
CARDIAC CAMERA
K833811 · IYX
Siemens Gammasonics, Inc.
Radiology · 104d
Cleared Dec 27, 1983
BIOTHERM
K833839 · ILJ
Trileen, Inc.
Physical Medicine · 54d
Cleared Dec 27, 1983
TUCK-TITE COLON FLUID RETAINER
K833860 · FCE
Clayton Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Dec 27, 1983
ACE/KYLE SELF TAPPING CANNULATED TITA
K833866 · JPW
Buckman Co., Inc.
Ear, Nose, Throat · 50d
Cleared Dec 27, 1983
UNIVERSAL CONTROL ARM
K833871 · CAI
Anesthesia Assoc., Inc.
Anesthesiology · 49d
Cleared Dec 27, 1983
CARDIOPULMONARY RESUSCITATOR
K833879 · DRM
Michigan Instruments, Inc.
Cardiovascular · 49d
Cleared Dec 27, 1983
TEMPTREND II
K833904 · KPD
Biosynergy, Inc.
General Hospital · 43d
Cleared Dec 27, 1983
KELLY CHOLANGIOCATH
K833920 · FGE
Perry, Div.
Gastroenterology & Urology · 43d
Cleared Dec 27, 1983
ELECTRO-MYOSCOPE 85
K833927 · IKN
Biomedical Design Instruments
Neurology · 43d