FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84289–84312 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 1999
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
K993310 · JJY
Dade Behring, Inc.
Chemistry · 57d
Cleared Nov 30, 1999
K-ASSAY IGM
K993323 · CFF
Kamiya Biomedical Co.
Immunology · 57d
Cleared Nov 30, 1999
RETIC-QUINOX
K993496 · JPK
Hematronix, Inc.
Hematology · 46d
Cleared Nov 30, 1999
K-ASSAY TRANSFERRIN
K993537 · DDG
Kamiya Biomedical Co.
Immunology · 42d
Cleared Nov 30, 1999
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3
K993546 · JJY
Medical Analysis Systems, Inc.
Immunology · 42d
Cleared Nov 30, 1999
ELECSYS PARATHYROID HORMONE CALCHECK
K993642 · JJX
Roche Diagnostics Corp.
Immunology · 33d
Cleared Nov 30, 1999
PARA TECH PLUS RETICS
K993825 · JCN
Streck Laboratories, Inc.
Hematology · 18d
Cleared Nov 29, 1999
HYBRID CAPTURE II GC-ID
K981485 · LSL
Digene Corp.
Microbiology · 584d
Cleared Nov 29, 1999
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K992862 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 96d
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