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
159889–159912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1982
MALLINCKRODT DIAG. MEDIA WARMER
K821401 · DXT
Forma Scientific, Inc.
Cardiovascular · 37d
Cleared Jun 17, 1982
WILLIAM HARVEY FLEX. VENOUS RESERVOIR
K821442 · DTN
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Jun 17, 1982
ENDOTRACHEAL TUBE
K821456 · BTR
Life-Line Products, Inc.
Anesthesiology · 34d
Cleared Jun 17, 1982
RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT
K821480 · DQY
The Healthcare Group Laboratories, Inc.
Cardiovascular · 30d
Cleared Jun 17, 1982
MEDICOTEST ECG ELECTRODES
K821506 · DRX
Medicotest, Inc.
Cardiovascular · 27d
Cleared Jun 16, 1982
VIRAGARD/VIRASHIELD
K820459 · DRS
Tri-Med, Inc.
Cardiovascular · 117d
Cleared Jun 16, 1982
THERMA-SCAN
K820941
T. G. & E. Medical
General Hospital · 71d
Cleared Jun 16, 1982
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K821261 · KRH
Shiley, Inc.
Cardiovascular · 44d
Cleared Jun 16, 1982
MAGUN BASE I.V. POLE
K821405 · FOX
Manuco Manufacturing Co., Inc.
General Hospital · 36d
Cleared Jun 16, 1982
STERILE TRACHEOSTOMY CARE KIT
K821501 · KDD
Pro-Pak
General & Plastic Surgery · 28d
Cleared Jun 16, 1982
OMNI TENS
K821523 · GZJ
Omni Intl., Inc.
Neurology · 26d
Cleared Jun 16, 1982
DESERET ANGIO GUIDE
K821577 · FOZ
Warner-Lambert Co.
General Hospital · 19d
Cleared Jun 16, 1982
CERVISCOPE OPTICAL SYSTEM
K821616 · HEX
Fotomedics, Inc.
Obstetrics & Gynecology · 14d
Cleared Jun 16, 1982
LATEX PENROSE DRAIN TUBING
K821700 · GAX
Abco Dealers, Inc.
General & Plastic Surgery · 8d
Cleared Jun 14, 1982
PLASTIC OR GLASS MAGNIFIER
K820375 · HJF
Gazelle Corp.
Ophthalmic · 125d
Cleared Jun 14, 1982
CILCO I/A HANDPIECE
K820933 · HQE
Cilco, Inc.
Ophthalmic · 73d
Cleared Jun 14, 1982
CHART PROJECTOR
K821081 · HOJ
Medical Equipment Designs, Inc.
Ophthalmic · 56d
Cleared Jun 14, 1982
TRIAL LENS SET
K821082 · HLH
Medical Equipment Designs, Inc.
Ophthalmic · 56d
Cleared Jun 14, 1982
P.D. METER
K821083 · HLH
Medical Equipment Designs, Inc.
Ophthalmic · 56d
Cleared Jun 14, 1982
UNIVERSAL TRIAL FRAMEE
K821084 · HPA
Medical Equipment Designs, Inc.
Ophthalmic · 56d
Cleared Jun 14, 1982
EXOPHTHALMOMETER
K821107 · HCS
Medical Equipment Designs, Inc.
Neurology · 55d
Cleared Jun 14, 1982
YSI #24 & 24M GLUCOSE ANALYZERS
K821192 · CGA
Yellow Springs Instrument Co., Inc.
Chemistry · 48d
Cleared Jun 14, 1982
IOL FORCEPS
K821381 · KYB
Cilco, Inc.
Ophthalmic · 35d
Cleared Jun 14, 1982
V LANCE
K821440 · HNN
Sharpoint, Inc.
Ophthalmic · 32d