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
160681–160704 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1982
RAICHEM TM CREATINE KINASE REAGENT
K820644 · CGS
Reagents Applications, Inc.
Chemistry · 23d
Cleared Apr 01, 1982
EXHALED HYDROGEN MONITOR
K820652
Keymed, Inc.
Chemistry · 23d
Cleared Apr 01, 1982
CM10 CENTRAL MONITORING SYSTEM
K820671 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 21d
Cleared Apr 01, 1982
BILIRUBIN(TOTAL) DETERMINATION CTMS
K820675 · CIG
The Dow Chemical Co.
Chemistry · 21d
Cleared Apr 01, 1982
LIQUISOL PROGESTERONE RADIOIMMUNO
K820686 · JLS
Damon Corp.
Chemistry · 21d
Cleared Apr 01, 1982
DUPONT AUTOMATIC CLINICAL ANALYZER
K820687 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 21d
Cleared Apr 01, 1982
SYVA ADVANCE STANDARDIZATION KIT 01
K820698 · JIS
Syva Co.
Chemistry · 17d
Cleared Apr 01, 1982
EXTERNAL STANDARDS-SODIUMNPOTASSIUM
K820700 · JIX
Shaban Mfg. Co.
Chemistry · 17d
Cleared Apr 01, 1982
NOVA I FLUIDS PACK
K820701 · JIX
Shaban Mfg. Co.
Chemistry · 17d
Cleared Apr 01, 1982
GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL
K820705 · JJS
United Diagnostics, Inc.
Chemistry · 16d
Cleared Apr 01, 1982
NEONATAL INTRODUCER KIT
K820710 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 14d
Cleared Apr 01, 1982
DOW BILIRUBIN(DIRECT) DETERMINATION
K820714 · CIG
The Dow Chemical Co.
Chemistry · 17d
Cleared Apr 01, 1982
MONOJECT CORVAC STAT VAC TUBE W/THROM
K820717 · JKA
Sherwood Medical Co.
Hematology · 16d
Cleared Apr 01, 1982
COMPUTERIZED INTERPRETATION OF ARTERIAL
K820721 · JQP
Philip R. Corsello, M.D.
Chemistry · 16d
Cleared Apr 01, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
K820722 · JHS
Eastman Kodak Company
Chemistry · 16d
Cleared Apr 01, 1982
KODAK EKTACHEM CLINICAL CHEM. NH3
K820723 · JID
Eastman Kodak Company
Chemistry · 16d
Cleared Apr 01, 1982
DIASCOPE 2
K820745 · DRT
Puritan Bennett Corp.
Cardiovascular · 13d
Cleared Apr 01, 1982
FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3
K820790 · FAM
American Optical Corp.
Gastroenterology & Urology · 9d
Cleared Mar 31, 1982
DATASCOPE MODIFIED #82 IABP SYSTEM
K813182 · DSP
Datascope Corp.
Cardiovascular · 139d
Cleared Mar 31, 1982
EPCOM EMS SCAN II
K813275 · IYO
Epcom Medical Systems, Inc.
Radiology · 128d
Cleared Mar 31, 1982
HEMOFILTERS
K813591 · KDI
Amicon, Inc.
Gastroenterology & Urology · 93d
Cleared Mar 31, 1982
DELTA PLAN II RADIATION THERAPY PLAN
K820310 · IYE
Technicare Corp.
Radiology · 54d
Cleared Mar 31, 1982
AM. PH. STERILE PLASTIC CONNECTING TUBES
K820412 · BYY
American Pharmaseal Div. Ahsc
General Hospital · 47d
Cleared Mar 31, 1982
ARS-1000
K820448 · IYE
Applied Radiation
Radiology · 41d