FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132817–132840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 1989
HAND HELD NEBULIZER SYSTEM
K884947 · CAF
Salter Labs
Anesthesiology · 84d
Cleared Feb 17, 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Feb 17, 1989
ALKALINE PHOSPHATASE ISOENZYME SYSTEM
K885024 · CIN
Ciba Corning Diagnostics Corp.
Chemistry · 74d
Cleared Feb 17, 1989
HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275
K885079 · LPP
Mennen Medical, Inc.
Anesthesiology · 71d
Cleared Feb 17, 1989
EMIT THYROXINE ASSAY
K885141 · KLI
Syva Co.
Chemistry · 64d
Cleared Feb 17, 1989
AMYLASE SR LIQUID STABLE REAGENT SET
K885176 · JFJ
Medical Analysis Systems, Inc.
Chemistry · 65d
Cleared Feb 17, 1989
RMI SHORT DISTANCE ALIGNMENT DEVICE
K885223 · LNH
Radiation Measurements, Inc.
Radiology · 59d
Cleared Feb 17, 1989
TECHNICON AXON(TM) SYSTEM
K885226 · JJE
Technicon Instruments Corp.
Chemistry · 59d
Cleared Feb 17, 1989
ACA THYROXINE (T4 E) METHOD
K885258 · KLI
The DU Pont Co.
Chemistry · 56d
Cleared Feb 17, 1989
ACA THYRONINE UPTAKE (TU E) METHOD
K885259 · KHQ
The DU Pont Co.
Chemistry · 56d
Cleared Feb 17, 1989
DIGITRON 3, LV ANALYSIS PROTCOL
K885318 · LLZ
Siemens Gammasonics, Inc.
Radiology · 49d
Cleared Feb 17, 1989
HEMA(PRO)TEC(TION)
K885324 · GIO
Medical Products Search, Inc.
Hematology · 51d
Cleared Feb 17, 1989
BIOTROL CHLORIDE
K890015 · CHJ
Biotrol, USA, Inc.
Chemistry · 45d
Cleared Feb 17, 1989
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
K890023 · LBR
Sigma Diagnostics, Inc.
Chemistry · 44d
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