Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
144985–145008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1986
EMDS ENZYME VERIFIER, LEVELS I & II
K860764 · JJT
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 07, 1986
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
K860765 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Apr 07, 1986
SAMPLE MANIFOLD HOLDER
K860889 · FMG
R. Bell
General Hospital · 28d
Cleared Apr 07, 1986
EASY-TEST URIC ACID (URIC), #67516/93
K860916 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 07, 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
K860917 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Apr 07, 1986
GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS
K860938 · KDI
Gambro, Inc.
Gastroenterology & Urology · 26d
Cleared Apr 07, 1986
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED
K861068 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 18d
Cleared Apr 07, 1986
CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)
K861080 · JSM
Difco Laboratories, Inc.
Microbiology · 17d
Cleared Apr 07, 1986
AVL MODEL 983 ELECTROLYTE ANALYZER
K861087 · JGS
Avl Scientific Corp.
Chemistry · 17d
Cleared Apr 07, 1986
FRESENIUS HEMOFLOW F80 DIALYZER
K861106 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 07, 1986
KODAK AUTOMIXER II
K861225 · IXW
Eastman Kodak Company
Radiology · 6d
Cleared Apr 04, 1986
EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA
K853094 · EBI
Psp Dental Co., Ltd.
Dental · 255d
Cleared Apr 04, 1986
HONEYWELL ELECTRONIC VENTILATOR EV-A
K853501 · CBK
Honeywell, Inc.
Anesthesiology · 227d
Cleared Apr 04, 1986
VES-TEC/VES-MATIC
K854223 · CKB
Marvic Interpharma, Inc.
Hematology · 168d
Cleared Apr 04, 1986
DIGITAL-9 KEY LEUCOCYTE COUNTER
K854685 · GKM
Future Impex Corp.
Hematology · 135d
Cleared Apr 04, 1986
MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI
K854833 · GEX
Meditec, Inc.
General & Plastic Surgery · 126d
Cleared Apr 04, 1986
BAUSCH & LOMB LENS CARRYING CASE
K854968 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 114d
Cleared Apr 04, 1986
KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE
K855086 · ITI
Kempf Co.
Physical Medicine · 105d
Cleared Apr 04, 1986
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
K860122 · JBP
Medical Device Consultants, Inc.
Hematology · 80d
Cleared Apr 04, 1986
PICOSCALE BLOOD CELL COUNTER, MODEL PS-5
K860166 · GKL
Diagnostic Technology, Inc.
Hematology · 77d
Cleared Apr 04, 1986
GUNKEL CHROMAGRAPH COLOR VISION TESTER
K860174 · HIW
Chromagraphics, Inc.
Ophthalmic · 77d
Cleared Apr 04, 1986
KULTSURE (CULTURE TRANSPORT)
K860178 · JSM
Ncs Diagnostics, Inc.
Microbiology · 77d
Cleared Apr 04, 1986
UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER
K860185 · GZB
Neuromed, Inc.
Neurology · 73d
Cleared Apr 04, 1986
KYOCERA BIOCERAM POROUS DENTAL IMPLANT
K860360 · DZE
Kyocera International, Inc.
Dental · 64d