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
170953–170976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1978
PAPILLOTOMY KNIVES
K780774 · KNS
Olympus Corp.
Gastroenterology & Urology · 85d
Cleared Jul 27, 1978
STILITH CARDIAC PACEMAKERS-M. 60 & 120
K780781 · DXY
R.E. Brown Co., Inc.
Cardiovascular · 76d
Cleared Jul 27, 1978
IRRIGATION CAP
K780794 · KYZ
Travenol Laboratories, S.A.
General Hospital · 73d
Cleared Jul 27, 1978
GLOBIN-TERGE
K780817
Simmler & Son, Inc.
Hematology · 70d
Cleared Jul 27, 1978
URINARY CATHETERIZATION SYSTEM W/O FOLEY
K780831 · KNX
Medical Devices, Inc.
Gastroenterology & Urology · 66d
Cleared Jul 27, 1978
URINARY DRAINAGE BAG
K780837 · KNX
Intermed, Inc.
Gastroenterology & Urology · 65d
Cleared Jul 27, 1978
IN VITRO NEONATAL T4
K780854 · CDX
Clinical Assays, Inc.
Microbiology · 66d
Cleared Jul 27, 1978
PRINCETON BIOMEDIX URICASE (UV)
K780859 · CDO
Bd Becton Dickinson Vacutainer...
Chemistry · 64d
Cleared Jul 27, 1978
PREP I AUTOMATED SAMPLE PROCESSOR
K780933 · LDM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 50d
Cleared Jul 27, 1978
CONDUCTIVE CUSHION
K780941 · KIC
Markham Service Co., Inc.
Physical Medicine · 50d
Cleared Jul 27, 1978
BUN TEST UNI-UV BLOOD UREA NITROGEN TEST
K780943 · CDQ
Sclavo, Inc.
Hematology · 50d
Cleared Jul 27, 1978
LIQUID CHROMATOGRAPH MODEL 850
K780944 · KZR
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 49d
Cleared Jul 27, 1978
LIQUID CHROMATOGRAPH MODEL 860
K780945 · KZR
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 49d
Cleared Jul 27, 1978
ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER
K780946 · JPJ
Hycel, Inc.
Hematology · 48d
Cleared Jul 27, 1978
AUTOMATED ENZYME
K780962 · KSK
Hyland Therapeutic Div., Travenol...
Hematology · 45d
Cleared Jul 27, 1978
TRANSPORT INCUBATOR
K780964 · FPL
Cavitron Corp.
General Hospital · 45d
Cleared Jul 27, 1978
BURETTE SET WITH AIR CONTROL LEVER
K780970 · FPA
Travenol Laboratories, S.A.
General Hospital · 45d
Cleared Jul 27, 1978
SIGNAPAD
K780973 · GYB
Parker Laboratories, Inc.
Neurology · 45d
Cleared Jul 27, 1978
BACILLUS PUMILUS
K780974 · FRL
Urol, Inc.
Radiology · 48d
Cleared Jul 27, 1978
PLATELET CONTROL
K780980 · JPK
Bhp Diagnostix, Inc.
Hematology · 45d
Cleared Jul 27, 1978
CALCIUM REAGENT SYSTEM NO. 585
K780983 · CIC
Sigma Chemical Co.
Chemistry · 43d
Cleared Jul 27, 1978
PVC LINES FOR MONITORING
K780985 · GAZ
Norton Performance Plastics Corp.
General Hospital · 43d
Cleared Jul 27, 1978
AMALGAM ALLOY
K780997 · EJJ
Syntex Corp.
Dental · 43d
Cleared Jul 27, 1978
SCALPEL
K780998 · GDX
Isolab, Inc.
General & Plastic Surgery · 43d