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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
73345–73368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2003
AIGIS-A
K024140 · EJT
Sb Lucius, Inc.
Dental · 80d
Cleared Mar 06, 2003
NEO 76
K024141 · EJT
Sb Lucius, Inc.
Dental · 80d
Cleared Mar 06, 2003
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K024353 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Mar 06, 2003
KMEDIC EXTERNAL FIXATION DEVICES
K030336 · JDW
Teleflex Medical Group
Orthopedic · 34d
Cleared Mar 06, 2003
MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K030372 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Mar 06, 2003
ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
K030373 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 30d
Cleared Mar 06, 2003
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
K030377 · MNI
Synthes (Usa)
Orthopedic · 29d
Cleared Mar 06, 2003
REPICCI LOCKED KEEL TIBIAL BEARING
K030446 · HRY
Biomet, Inc.
Orthopedic · 23d
Cleared Mar 06, 2003
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462 · KFM
Cobe Cardiovascular, Inc.
Cardiovascular · 22d
Cleared Mar 06, 2003
SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES
K030483 · LYZ
Emerald Medical, Inc.
General Hospital · 20d
Cleared Mar 06, 2003
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
K030484 · LYZ
Emerald Medical, Inc.
General Hospital · 20d
Cleared Mar 06, 2003
INTERA FAMILY
K030520 · LNH
Philips Medical Systems North America...
Radiology · 15d
Cleared Mar 05, 2003
DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
K021533 · FXX
Creative Contract (M) Sdn Bhd
General Hospital · 299d
Cleared Mar 05, 2003
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH...
K021539 · FXX
Creative Contract (M) Sdn Bhd
General Hospital · 299d
Cleared Mar 05, 2003
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
K021546 · FXX
Creative Contract (M) Sdn Bhd
General Hospital · 299d
Cleared Mar 05, 2003
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
K022412 · KDJ
Fresenius Medical Care North America
Gastroenterology & Urology · 224d
Cleared Mar 05, 2003
CIMOFLUOR
K023888 · EMA
Global Dental Products, Inc.
Dental · 104d
Cleared Mar 05, 2003
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065 · DTN
Gish Biomedical, Inc.
Cardiovascular · 86d
Cleared Mar 05, 2003
IVD CRYPTO/GIARDIA DFA
K024113 · MHI
Ivd Research, Inc.
Microbiology · 82d
Cleared Mar 05, 2003
SMEARCLEAR
K024198 · KJJ
Sybron Dental Specialties, Inc.
Dental · 75d
Cleared Mar 05, 2003
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
K030075 · LZA
Best Manufacturing...
General Hospital · 56d
Cleared Mar 05, 2003
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
K030449 · DTN
Terumo Corp.
Cardiovascular · 22d
Cleared Mar 05, 2003
3.0T TORSO PHASED ARRAY COIL
K030495 · MOS
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Mar 04, 2003
ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
K021878 · LPH
Eska America Corp.
Orthopedic · 270d