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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83785–83808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1999
MAC-LAB SYSTEM
K992948 · DQK
General Electric Medical Systems...
Cardiovascular · 90d
Cleared Nov 29, 1999
SURE BOND
K993013 · KLE
Miradent Distributing Co., LLC
Dental · 83d
Cleared Nov 29, 1999
OPC LOW WEAR OPAQUE PORCELAIN
K993249 · EIH
Jeneric/Pentron, Inc.
Dental · 62d
Cleared Nov 29, 1999
K-ASSAY C4
K993481 · DBI
Kamiya Biomedical Co.
Immunology · 46d
Cleared Nov 29, 1999
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
K993721 · KPI
Laborie Medical Tech Corp.
Gastroenterology & Urology · 26d
Cleared Nov 28, 1999
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K993646 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Nov 26, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
K981914 · JJX
The Binding Site, Ltd.
Immunology · 543d
Cleared Nov 26, 1999
NASAL AIRE
K990659 · BZD
Breathing Technologies Corp.
Anesthesiology · 270d
Cleared Nov 26, 1999
SYNEFLASH & SYNEVIEW
K990727 · DQK
Ela Medical, Inc.
Cardiovascular · 266d
Cleared Nov 26, 1999
PBN DILATORS
K990808 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 260d
Cleared Nov 26, 1999
ECG ELECTRODE (VARIOUS)
K991105 · DRX
Conmedcorp
Cardiovascular · 239d
Cleared Nov 26, 1999
SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC
K991850 · LCP
Biosafe Laboratories, Inc.
Hematology · 178d
Cleared Nov 26, 1999
MACRA LP(A) ENZYME IMMUNOASSAY KIT
K992665 · DFC
Trinity Biotech USA
Chemistry · 109d
Cleared Nov 26, 1999
HICHEM ISE ELECTROLYTE REFERENCE
K992842 · JGS
Elan Holdings, Inc.
Chemistry · 94d
Cleared Nov 26, 1999
HICHEM ISE ELECTROLYTE BUFFER
K992844 · JGS
Elan Holdings, Inc.
Chemistry · 94d
Cleared Nov 26, 1999
DASH 3000 PATIENT MONITOR
K992929 · MHX
General Electric Medical Systems...
Cardiovascular · 87d
Cleared Nov 26, 1999
CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
K992965 · DRF
Cordis Webster, Inc.
Cardiovascular · 85d
Cleared Nov 26, 1999
MODIFICATION TO DOCUMENT THYROID CAL.VER
K993014 · JJY
Casco-Nerl Diagnostics Corporation...
Immunology · 79d
Cleared Nov 26, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
K993023 · JJY
Beckman Coulter, Inc.
Immunology · 78d
Cleared Nov 26, 1999
CD-CHEX CD 34
K993126 · GGL
Streck Laboratories, Inc.
Hematology · 67d
Cleared Nov 26, 1999
PRIMUS
K993425 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Nov 26, 1999
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
K993473 · DLJ
Beckman Coulter, Inc.
Toxicology · 43d
Cleared Nov 26, 1999
VARELISA RNP ANTIBODIES
K993589 · LKO
Pharmacia & Upjohn Co.
Immunology · 35d
Cleared Nov 26, 1999
K-ASSAY APO A1/B CALIBRATOR SET
K993606 · JIX
Kamiya Biomedical Co.
Chemistry · 32d