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
169705–169728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1979
HYCEL M
K790335 · JJF
Hycel, Inc.
Chemistry · 6d
Cleared Feb 26, 1979
EKG, SWITCHING BLADE AND PENS
K781799 · GEI
Bionex, Inc.
General & Plastic Surgery · 126d
Cleared Feb 26, 1979
ELECTROSURGERY MODEL 771
K781949 · GEI
Birtcher Corp.
General & Plastic Surgery · 97d
Cleared Feb 26, 1979
SERACON-N
K782039 · JIX
Bhp Diagnostix, Inc.
Chemistry · 82d
Cleared Feb 26, 1979
DEBUTRON
K782119 · KCX
Martin Electric Co.
General & Plastic Surgery · 61d
Cleared Feb 26, 1979
IEC CENTRA-7 CENTRIFUGE MODEL 2362
K782124 · JQC
Damon Corp.
Chemistry · 61d
Cleared Feb 26, 1979
PLETHYSMOGRAPH, STRAIN GAUGE
K782132 · JOM
Medasonics, Inc.
Cardiovascular · 61d
Cleared Feb 26, 1979
IMPRESSION TRAY, MDDS CUSTOM
K782153 · EBH
Chayet and Sonnenrich, P.C.
Dental · 62d
Cleared Feb 26, 1979
I TESTOTERONE
K790007 · CDZ
Cambridge Nuclear Corp.
Immunology · 55d
Cleared Feb 26, 1979
I ESTRIOL
K790008 · CGI
Cambridge Nuclear Corp.
Immunology · 55d
Cleared Feb 26, 1979
SERUM, GLUTAMIC-OXALOACETIC
K790017 · CIT
Fisher Scientific Co., LLC
Chemistry · 54d
Cleared Feb 26, 1979
SERUM, URIC ACID DETERMINATION
K790019 · CDH
Fisher Scientific Co., LLC
Chemistry · 54d
Cleared Feb 26, 1979
FLUID, RHEMOX W LYSING
K790029 · GGK
Sysmex Corp.
Hematology · 54d
Cleared Feb 26, 1979
CARDIAC OUTPUT COMPUTER, MDEL 9520A
K790047 · DXG
Edwards Laboratories
Cardiovascular · 52d
Cleared Feb 26, 1979
SURGICAL RULER AND PEN
K790084 · FZZ
Devon Industries, Inc.
General & Plastic Surgery · 41d
Cleared Feb 26, 1979
DETERMINATION OF ANTITHROMBIN III, 885
K790090 · JBQ
Sigma Chemical Co.
Hematology · 41d
Cleared Feb 26, 1979
SALIVAN PARAEIGHT TOUGHNESS
K790096 · EJS
Den-Mat Corp.
Dental · 41d
Cleared Feb 26, 1979
SALIVAN & SALIVAN BROWN
K790097 · EJS
Den-Mat Corp.
Dental · 41d
Cleared Feb 26, 1979
MOBILE UNITS, I,II,III,IV
K790112 · EIA
Dentsply Intl.
Dental · 38d
Cleared Feb 26, 1979
MIDWEST 1000
K790113 · EFB
Midwest
Dental · 38d
Cleared Feb 26, 1979
CEMENT, CERAMCO
K790127 · EMA
Johnson & Johnson Professionals, Inc.
Dental · 34d
Cleared Feb 26, 1979
NEEDLE, WITH FILTER
K790142 · GAA
National Patent Development Corp.
General & Plastic Surgery · 38d
Cleared Feb 26, 1979
PROTECTIVSTABILIZER
K790186 · GBJ
Jelco Laboratories
General & Plastic Surgery · 28d
Cleared Feb 26, 1979
FOOT VALVE
K790195 · GET
American Safety
General & Plastic Surgery · 33d