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
151369–151392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1984
MAXAMAN
K841893 · BTL
Cryo2 Corp.
Anesthesiology · 115d
Cleared Aug 30, 1984
LIFE MONITOR I
K842334 · CCK
St. Croix Medical Systems, Inc.
Anesthesiology · 78d
Cleared Aug 30, 1984
AMERICAN PHARMASEAL I.V. START KIT
K842860
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 38d
Cleared Aug 29, 1984
TDX DISOPYRAMIDE
K842713 · LBZ
Abbott Laboratories
Chemistry · 48d
Cleared Aug 29, 1984
PORTABLE LIFECARE VENTILATOR PLV-102
K842876 · CBK
Lifecare Services, Inc.
Anesthesiology · 37d
Cleared Aug 29, 1984
CHAD ADJUSTABLE CANNULA
K842968 · CAT
Chad Therapeutics, Inc.
Anesthesiology · 30d
Cleared Aug 29, 1984
ALLERGENTICS TOTAL IGE/THEOPHYLLINE
K842970 · JJY
Allergenetics
Chemistry · 30d
Cleared Aug 29, 1984
UNIVERSAL 2 S CENTRIFUGE
K843087 · JQC
Boehringer Mannheim Corp.
Chemistry · 23d
Cleared Aug 29, 1984
EBA 3 S CENTRIFUGE
K843088 · JQC
Boehringer Mannheim Corp.
Chemistry · 23d
Cleared Aug 29, 1984
MEDTRONIC 8437/8438
K843089 · DXY
Medtronic Vascular
Cardiovascular · 23d
Cleared Aug 29, 1984
SYSTEMATE CALCIUM 67214
K843152 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 19d
Cleared Aug 29, 1984
EMIT 700 COCAINE METABOLITE ASSAY
K843160 · DIO
Syva Co.
Toxicology · 19d
Cleared Aug 29, 1984
EMIT 700 CONTROL SET A
K843161 · DIF
Syva Co.
Toxicology · 19d
Cleared Aug 28, 1984
LIFESCOPE II
K841499 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6201
K841500 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6102
K841501 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6105
K841502 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 28, 1984
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
K842468 · CZP
Miles Laboratories, Inc.
Immunology · 64d
Cleared Aug 28, 1984
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM
K842470 · DFH
Miles Laboratories, Inc.
Immunology · 64d
Cleared Aug 28, 1984
AMIZYME-LEISHMANIA SPP. TEST KIT
K842526 · LOO
Amico Lab, Inc.
Immunology · 61d
Cleared Aug 28, 1984
ANTI-TOXOPLASMA GONDII KIT
K842664 · GLZ
Amico Lab, Inc.
Immunology · 49d
Cleared Aug 28, 1984
FIAX TOTAL IGE TEST KIT
K842749 · DGP
Intl. Diagnostic Technology
Immunology · 46d
Cleared Aug 28, 1984
PMK PRIMARY MONKEY KIDNEY-CELLS
K842833 · KJR
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 39d
Cleared Aug 28, 1984
HEP-2 CELLS
K842834 · KJR
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 39d