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

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176,076 results
153577–153600 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1984
LENS INSERTION GLIDE
K840694 · KYB
Innovative Surgical Products, Inc.
Ophthalmic · 83d
Cleared May 09, 1984
CORNEAL SCLERAL LANCE
K840855 · HNN
Sharpoint, Inc.
Ophthalmic · 75d
Cleared May 09, 1984
TSE-ANDERSON MODIFIED LACRIMAL GROOV
K840861 · HNL
Hansen Ophthalmic Development Lab
Ophthalmic · 75d
Cleared May 09, 1984
SITE COAXIAL I/A HANDPIECE 30 TIP
K840965 · HQC
Chiron Vision Corp.
Ophthalmic · 64d
Cleared May 09, 1984
LACHRYMAL PROBES-VARIOUS
K841002 · HNW
Premier Dental Products Co.
Ophthalmic · 61d
Cleared May 09, 1984
OPHTHALMIC CURETTE-VARIOUS
K841007 · HNZ
Premier Dental Products Co.
Ophthalmic · 61d
Cleared May 09, 1984
VENTREZYME T4U IMMUNOASSAY T4U
K841024 · CEE
Ventrex Laboratories, Inc.
Chemistry · 58d
Cleared May 09, 1984
CHARLES/MCINTYRE GIANT BREAK TABLE
K841115 · FQO
Surgi-Quip Inc.U
General & Plastic Surgery · 55d
Cleared May 09, 1984
MOBILE OPHTHALMIC OPERATING TABLE
K841116 · FWX
Surgi-Quip Inc.U
General & Plastic Surgery · 55d
Cleared May 09, 1984
STERILIZATION PROCESS INDICATOR
K841168 · JOJ
Parke-Davis Co.
General Hospital · 51d
Cleared May 09, 1984
ASTRA SYS INORGANIC PHOSPHORUS CHEM
K841181 · CEO
Beckman Instruments, Inc.
Chemistry · 50d
Cleared May 09, 1984
MULTIPLE CHEM. MODULE FOR ANALYSIS
K841182 · CHH
Beckman Instruments, Inc.
Chemistry · 50d
Cleared May 09, 1984
SPECTACLE INDIRECT OPHTHALMOSCOPE
K841292 · HLJ
Keller Instruments, Inc.
Ophthalmic · 41d
Cleared May 09, 1984
PANORAMIC LOUPES - VARIOUS
K841293 · HLT
Keller Instruments, Inc.
Ophthalmic · 41d
Cleared May 09, 1984
REPLACE-A-TIP RECHARG. LOW TEMP.
K841325 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 37d
Cleared May 09, 1984
REPLACE-A-TIP RECHARGEABLE HIGH TEMP
K841326 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 37d
Cleared May 09, 1984
CIVCO/SUPER SCAN
K841332 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 37d
Cleared May 09, 1984
KOLLMANN URETHRAL DILATOR
K841386 · KOE
Imm Enterprises , Ltd.
Gastroenterology & Urology · 43d
Cleared May 09, 1984
WESTON RECTAL SNARE
K841387 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 43d
Cleared May 09, 1984
INTELECT 205 PORTABLE ULTRASOUND UNIT
K841445 · IMI
Chattanooga Group, Inc.
Physical Medicine · 33d
Cleared May 09, 1984
INTELECT 200 THERAPEUTIC ULTRASOUND
K841446 · IMI
Chattanooga Group, Inc.
Physical Medicine · 33d
Cleared May 09, 1984
INTELECT 210 PORTABLE ULTRASOUND
K841447 · IMI
Chattanooga Group, Inc.
Physical Medicine · 33d
Cleared May 09, 1984
UROLOGICAL KIT W/STERILE, WATER-FILL
K841485 · KOD
Medline Industries, Inc.
Gastroenterology & Urology · 29d
Cleared May 09, 1984
CONVAID - SPEECH AID
K841528 · ILQ
Convaid , Ltd.
Physical Medicine · 27d