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
110545–110568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1994
UROPAPER EIKEN 6B
K932368 · JIL
Tanabe U.S.A., Inc.
Chemistry · 269d
Cleared Jan 13, 1994
EC 5R PLETHYSMOGRAPH
K932812 · JEH
D. E. Hokanson, Inc.
Anesthesiology · 218d
Cleared Jan 13, 1994
PHX TECHNOLOGIES CORP., 5MM, 10MM, AND 12MM BLUNT-TIPPED TROCAR OBTURATORS...
K934279 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 135d
Cleared Jan 13, 1994
PHX TECHNOLOGIES CORP., 10 MM THORACOSCOPY SCRAPPER DEVICE
K934280 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 135d
Cleared Jan 13, 1994
AMPHETAMINES EIA ASSAY MODIFICATION
K934891 · DKZ
Diagnostic Reagents, Inc.
Toxicology · 114d
Cleared Jan 13, 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 79d
Cleared Jan 13, 1994
HYBRID SURGICAL DEVICE MODIFICATION
K935258 · GEX
Lca, Inc.
General & Plastic Surgery · 73d
Cleared Jan 13, 1994
BINAURAL HEARING AID
K935366 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 70d
Cleared Jan 13, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591 · LDJ
Microgenics Corp.
Toxicology · 55d
Cleared Jan 13, 1994
SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE
K935942 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 31d
Cleared Jan 12, 1994
ALLKARE BARRIER WIPE
K925004 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 467d
Cleared Jan 12, 1994
NEBULIZER PUMP, POWERED MODEL 1180
K925011 · BTI
Thomas Industries
Anesthesiology · 467d
Cleared Jan 12, 1994
MPM GELPAD (HYDROGEL SATURATED STERILE GAUZE PADS)
K933495 · MGQ
Marketing Professionals IN Medicine,...
General & Plastic Surgery · 177d
Cleared Jan 12, 1994
NEDBOND EJECTOR KERRISON RONGEUR
K933978 · HAE
Redmond Neurotechnologies Corp.
Neurology · 149d
Cleared Jan 12, 1994
SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE
K935797 · BSR
Stebar Instrument Corp.
Anesthesiology · 41d
Cleared Jan 12, 1994
BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
K935835 · BYX
Busse Hospital Disposables, Inc.
Anesthesiology · 36d
Cleared Jan 11, 1994
VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.
K922997 · LZF
Via Medical Corp.
General Hospital · 568d
Cleared Jan 11, 1994
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K930810 · CIN
Hybritech, Inc.
Chemistry · 328d
Cleared Jan 11, 1994
APOLLO CAMERA
K931136 · HET
Life Sensing Instrument Company, Inc.
Obstetrics & Gynecology · 312d
Cleared Jan 11, 1994
NUMED DISPOSABLE ATT. NUMED HANDLE LAP. INST.
K931501 · HET
Numed Technologies, Inc.
Obstetrics & Gynecology · 292d
Cleared Jan 11, 1994
ENTREE BLUNT TIP TROCAR AND ADAPTER
K932020 · HET
Core Dynamics, Inc.
Obstetrics & Gynecology · 263d
Cleared Jan 11, 1994
ENTREE CANNULA FASCIA ANCHORS
K932021 · FBM
Core Dynamics, Inc.
Gastroenterology & Urology · 263d
Cleared Jan 11, 1994
JARIT SURGICAL INSTRUMENTS
K932072 · HET
Medical Device Inspection Co., Inc.
Obstetrics & Gynecology · 258d
Cleared Jan 11, 1994
BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT
K933078 · MGA
Beckman Instruments, Inc.
Immunology · 202d