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
81817–81840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2000
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB...
K002849 · HNO
Surgical Specialties Corp
Ophthalmic · 35d
Cleared Oct 18, 2000
SUREONE INSULIN SYRINGE
K002921 · FMF
Hosuk Co., Ltd.
General Hospital · 29d
Cleared Oct 18, 2000
SOLAR SPO2 MODULE WITH MASIMO SET
K002957 · DQA
General Electric Medical Systems...
Anesthesiology · 26d
Cleared Oct 18, 2000
M2376A DEVICELINK SYSTEM, MODEL M2376A
K002967 · MWI
Agilent Technologies, Inc.
Cardiovascular · 26d
Cleared Oct 18, 2000
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
K003090 · EIA
Midmark Corp.
Dental · 15d
Cleared Oct 17, 2000
INSIGHT 4000 ENDOSCOPE
K000252 · MPA
Insight Instruments Mfg., Inc.
Ophthalmic · 264d
Cleared Oct 17, 2000
PROLITE PULSED LIGHT SYSTEM
K000929 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 209d
Cleared Oct 17, 2000
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS
K002198 · OWB
Fluoro Scan Imaging Systems, Inc.
Radiology · 89d
Cleared Oct 17, 2000
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
K002408 · LPL
Unilens Corp., USA
Ophthalmic · 71d
Cleared Oct 17, 2000
HITACHI ALTAIRE
K002420 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Oct 17, 2000
VISION 9000 PHASED ARRAY TORSO COIL
K002482 · MOS
Usa Instruments, Inc.
Radiology · 64d
Cleared Oct 17, 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 36d
Cleared Oct 17, 2000
XPS NITRO SYSTEM
K002828 · ERL
Xomed, Inc.
Ear, Nose, Throat · 36d
Cleared Oct 17, 2000
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
K002898 · GEI
Curon Medical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 17, 2000
HEADBAND FOR BAHA
K002913 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 29d
Cleared Oct 17, 2000
MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
K002936 · LLZ
Sectra-Imtec AB
Radiology · 26d
Cleared Oct 17, 2000
SMALL STATURE USS
K994121 · MNI
Synthes (Usa)
Orthopedic · 316d
Cleared Oct 16, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K002870 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 33d
Cleared Oct 16, 2000
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200...
K002922 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 27d
Cleared Oct 16, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · KWP
Encore Orthopedics, Inc.
Orthopedic · 24d
Cleared Oct 13, 2000
TC-PLUS SOLUTION KNEE
K000666 · JWH
Plus Orthopedics
Orthopedic · 228d
Cleared Oct 13, 2000
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K001578 · DQO
AngioDynamics, Inc.
Cardiovascular · 144d
Cleared Oct 13, 2000
FOCUS
K002147 · MUJ
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Oct 13, 2000
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
K002168 · EJI
Ronvig Instruments, Ltd.
Dental · 88d