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
132241–132264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1989
OPTI-TEARS(R)
K890303 · LPN
Alcon Laboratories
Ophthalmic · 25d
Cleared Feb 17, 1989
BICARBONATE TEST ITEM NUMBER: SR1006
K890305 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 25d
Cleared Feb 17, 1989
RFA/2 RAPID FLOW ANALYZER W/COMPUTER
K890332 · JJC
Alpkem Corp.
Chemistry · 25d
Cleared Feb 17, 1989
ALBUMIN REAGENT
K890333 · EIX
Alpkem Corp.
Chemistry · 25d
Cleared Feb 17, 1989
SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
K890335 · CGE
Alpkem Corp.
Chemistry · 25d
Cleared Feb 17, 1989
RYAN-STYLE DIRECTED INFUSION MANIPULATOR
K890398 · HBI
Advanced Surgical Products, Inc.
General & Plastic Surgery · 24d
Cleared Feb 17, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
K890415 · DEM
Atlantic Antibodies
Immunology · 24d
Cleared Feb 17, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR C3
K890417 · KTQ
Atlantic Antibodies
Immunology · 24d
Cleared Feb 17, 1989
V-TREND TARGET CRP TEST
K890423 · DCK
Texas Immunology, Inc.
Immunology · 22d
Cleared Feb 17, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR C4
K890564 · DBI
Atlantic Antibodies
Immunology · 24d
Cleared Feb 17, 1989
BITE BLOCK #59430
K890567 · JXL
Medi-Source, Inc.
Neurology · 11d
Cleared Feb 17, 1989
BION DIRECT IDENTIFICATION CONTROL SLIDE
K890616 · LJG
Bion Ent., Ltd.
Microbiology · 10d
Cleared Feb 17, 1989
JAMES REAGENT
K890625 · JTO
Dms Products, Inc.
Microbiology · 10d
Cleared Feb 16, 1989
PRO DISCS
K882630 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 234d
Cleared Feb 16, 1989
ALN DISCS
K882636 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 234d
Cleared Feb 16, 1989
ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270
K884312 · KPT
Atomic Products Corp.
Radiology · 126d
Cleared Feb 16, 1989
KODAK SURECELL HERPES (HSV) TEST KIT
K884680 · LGC
Eastman Kodak Company
Microbiology · 99d
Cleared Feb 16, 1989
CLINICAL ELECTRONIC THERMOMETERS
K884765 · FLL
Sheridan Catheter Corp.
General Hospital · 94d
Cleared Feb 16, 1989
ANGIOSTAR
K884912 · IZI
Siemens Medical Solutions USA, Inc.
Radiology · 80d
Cleared Feb 16, 1989
COULTER 5P CONTROL
K885028 · GKZ
Coulter Electronics, Inc.
Hematology · 73d
Cleared Feb 16, 1989
SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM
K885127 · LMC
Fischer Imaging Corp.
Radiology · 66d
Cleared Feb 16, 1989
EXPANDABLE BILIARY STENT ENDOPROSTHESIS
K885180 · FGE
Schneider Intl., Ltd.
Gastroenterology & Urology · 64d
Cleared Feb 16, 1989
MURINE MONOCLONAL ANTI-ADENOVIRUS IGG
K885310 · GNY
Whittaker Bioproducts, Inc.
Microbiology · 49d
Cleared Feb 16, 1989
KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000
K890097 · LMC
Eastman Kodak Company
Radiology · 37d