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
157345–157368 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1983
REFERENCE BUFFER PH 7.382
K831023 · CHL
Fisher Scientific Co., LLC
Chemistry · 77d
Cleared Jun 15, 1983
STROMA II
K831096 · EJS
Unitek Corp.
Dental · 72d
Cleared Jun 15, 1983
CONCERTO
K831097 · EJS
Unitek Corp.
Dental · 72d
Cleared Jun 15, 1983
COMMAND ULTRA I
K831161 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 65d
Cleared Jun 15, 1983
DELIVERY 4 TABLE
K831309 · KNC
Amsco Co.
Obstetrics & Gynecology · 54d
Cleared Jun 15, 1983
PMT VAXIOM STEREOTACTIC SYS #FX001
K831329 · HAW
Progress Mankind Technology
Neurology · 51d
Cleared Jun 15, 1983
AUTOANTIBODY SCREEN TEST SYSTEM
K831358 · DBM
Zeus Scientific, Inc.
Microbiology · 50d
Cleared Jun 15, 1983
METAL-BACKED ACETABULAR CUP
K831479 · DXQ
Dow Corning Corp. Healthcare...
Cardiovascular · 37d
Cleared Jun 15, 1983
VARI-SUPPORT NECK POSTURE PILLOW
K831582 · IQK
Body Therapeutics, Inc.
Physical Medicine · 29d
Cleared Jun 15, 1983
INSTRUMENT GUARD CAPSULE
K831588 · KCT
Treace Medical, Inc.
General Hospital · 29d
Cleared Jun 15, 1983
T-TUBE INSERTER
K831590 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 29d
Cleared Jun 15, 1983
CASTLE MODEL 3341 & 3441 & 4141 GAS AER
K831595 · FLI
Castle Co.
General Hospital · 29d
Cleared Jun 15, 1983
DROP FOOT BRACE
K831615 · IQI
Edward Dilauro, Jr.
Physical Medicine · 27d
Cleared Jun 14, 1983
BABY LIGHT METER
K837494
Rocky Mountain Medical Corp.
Radiology · 56d
Cleared Jun 14, 1983
INFRADIODE INFRARED LAMP
K837517
Phimo of Texas, Inc.
Radiology · 32d
Cleared Jun 13, 1983
REX PEDESTAL INTRA-ORAL X-RAY UNIT
K837491
The Yoshida Dental Mfg. Co., Ltd.
Radiology · 74d
Cleared Jun 13, 1983
UNKNOWN
K837513
Xerox Corp.
Radiology · 49d
Cleared Jun 12, 1983
URINE SCREENING KIT
K830824 · CEN
Syn-Kit, Inc.
Microbiology · 89d
Cleared Jun 11, 1983
ETHICON EXTERNAL FIXATION WIRE
K821178 · FYI
Ethicon, Inc.
General & Plastic Surgery · 410d
Cleared Jun 10, 1983
EYELID SPECULUM
K830430 · HNC
Douglas C. Mckee & Co.
Ophthalmic · 121d
Cleared Jun 10, 1983
LENSERT CONTACT LENS CLEANING & INSERT
K830738 · KYE
Jermyn Specialties of California
Ophthalmic · 94d
Cleared Jun 10, 1983
RADIAL IMMUNODIFFUSION PLATES
K830911 · DDG
Biocell Laboratories, Inc.
Immunology · 81d
Cleared Jun 10, 1983
ACOH WELLNESS TESTER
K830954 · BZC
Bradley, Campbell & Carney
Anesthesiology · 77d
Cleared Jun 10, 1983
AUTO REFRACTOMETER
K831083 · HKO
Nidek, Inc.
Ophthalmic · 67d