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
159433–159456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1982
STAND, SURG. INSTRUMENT & DRESSING
K821921 · FSH
Emerson-Sack-Warner Corp.
General & Plastic Surgery · 31d
Cleared Jul 30, 1982
TABLE, SURG. INSTRUMENT & DRESSING
K821927
Emerson-Sack-Warner Corp.
General & Plastic Surgery · 31d
Cleared Jul 30, 1982
HAEM-C PLUS BLOOD REFERENCE CONTROLS
K821956 · JCN
Baker Instructions Corp.
Hematology · 30d
Cleared Jul 30, 1982
BBL PNEUMOSLIDE TEST
K821960 · GWC
Bd Becton Dickinson Vacutainer...
Microbiology · 29d
Cleared Jul 30, 1982
BBL STAPHYSLIDE TEST
K821962 · JWX
Bd Becton Dickinson Vacutainer...
Microbiology · 29d
Cleared Jul 30, 1982
LEONARD PERIPHERAL VENOUS PRESSURE CATH
K821996 · DYG
Norton Performance Plastics Corp.
Cardiovascular · 23d
Cleared Jul 30, 1982
RESPICORD
K821998 · BWF
Novamed Products, Inc.
Anesthesiology · 23d
Cleared Jul 30, 1982
BINOCULAR OPERATING MICROSCOPES &
K822009 · EPT
Kelleher Corp.
General & Plastic Surgery · 22d
Cleared Jul 30, 1982
BINOCULAR OPERATING MICROSCOPES &
K822012 · HBN
Kelleher Corp.
Neurology · 22d
Cleared Jul 30, 1982
BINOCULAR OPERATING MICROSCOPES AND
K822015 · FSO
Kelleher Corp.
General & Plastic Surgery · 22d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN REAGENT STRIPS
K822044 · KHG
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN TEST MODULE
K822045 · KHG
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN CALIBRATORS
K822046 · KRZ
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 30, 1982
D645-BACTERIOLOGICAL GAS LINE FILTER
K822097 · KRI
Electromedics, Inc.
Cardiovascular · 14d
Cleared Jul 30, 1982
SHOVEL RETRACTOR
K822109 · NBH
Bio-Blitz, Inc.
Orthopedic · 11d
Cleared Jul 30, 1982
SECA DIGITAL BABY SCALE 727
K822135 · FRW
Seca Corp.
General Hospital · 10d
Cleared Jul 30, 1982
DIGISTIM II
K822137 · BXN
Beuro Technology
Anesthesiology · 11d
Cleared Jul 30, 1982
NEUROSTIM II
K822138 · BXN
Neuro Technology
Anesthesiology · 11d
Cleared Jul 30, 1982
TOMAC LUBRICATING JELLY
K822143 · KMJ
American Medical Systems, Inc.
General Hospital · 9d
Cleared Jul 30, 1982
PERIPHERAL NERVE STIMULATOR, MODEL A-200
K822157 · BXN
P.B. Services
Anesthesiology · 7d
Cleared Jul 28, 1982
C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP
K821328 · KPF
Medionics International , Ltd.
Gastroenterology & Urology · 85d
Cleared Jul 28, 1982
DISPO. AES.
K821671 · FMF
Hiraoka New York, Inc.
General Hospital · 51d
Cleared Jul 28, 1982
NORSEN DEBRIDER
K821801 · GED
Bel-Med, Inc.
General & Plastic Surgery · 43d
Cleared Jul 28, 1982
GAS STERILIZATION EQUIPMENT
K821842 · FLF
Getinge International, Inc.
General Hospital · 36d