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
153097–153120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1984
SPOT TEST NINHYDRIN REAGENTS
K842290 · JSF
Difco Laboratories, Inc.
Microbiology · 11d
Cleared Jun 22, 1984
SPOT TEST CATALASE TEST
K842291 · JSF
Difco Laboratories, Inc.
Microbiology · 11d
Cleared Jun 22, 1984
ISOSTATION LOWER BACK MACHINE
K842296 · IKK
Isotechnologies, Inc.
Physical Medicine · 11d
Cleared Jun 22, 1984
ARGINIE BROTH
K842297 · JSF
Remel Co.
Microbiology · 11d
Cleared Jun 22, 1984
ONPG DISKS
K842300 · JSF
Irvine Diagnostic Services
Microbiology · 11d
Cleared Jun 22, 1984
VITACOMM 100 ESOPHAGEAL STETHOSCOPE
K842309 · BZT
Vitacomm, Inc.
Anesthesiology · 10d
Cleared Jun 21, 1984
EMIT D.A.U. URINE CANNABINOID ASSAY
K834458 · LDJ
Syva Co.
Toxicology · 185d
Cleared Jun 21, 1984
EMIT ST URINE CANNABINOID ASSAY
K841238 · LDJ
Syva Co.
Toxicology · 90d
Cleared Jun 19, 1984
UNIVERSAL SELF-ALIGNING ACETABULAR COM
K834035 · JDI
Orthopedic Equipment Co., Inc.
Orthopedic · 209d
Cleared Jun 19, 1984
UNIVERSAL PACK
K834155 · HQE
Atlantic Optical Systems, Inc.
Ophthalmic · 200d
Cleared Jun 19, 1984
Q-MED ELECTRODE
K840465 · DRX
Qmed, Inc.
Cardiovascular · 137d
Cleared Jun 19, 1984
MANUAL IRRIGATING/ASPIRATING UNIT
K840495 · HQC
Alltek, Inc.
Ophthalmic · 134d
Cleared Jun 19, 1984
TOCO DATA TELEPHONE TRANSMITTER DT100P
K840747 · HFM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 117d
Cleared Jun 19, 1984
CAT 100
K840836 · HKX
CooperVision, Inc.
Ophthalmic · 116d
Cleared Jun 19, 1984
CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD
K840955 · JEY
Synthes (Usa)
Dental · 106d
Cleared Jun 19, 1984
OCTOPUS 500/500E
K841099 · HPT
Cilco, Inc.
Ophthalmic · 99d
Cleared Jun 19, 1984
MICROTRAKSPECIMAN ID TYPING TEST CONTR
K841191 · GQN
Syva Co.
Microbiology · 90d
Cleared Jun 19, 1984
ACCOMMOTRAC VISION TRAINER
K841273
Biofeedtrac, Inc.
Ophthalmic · 84d
Cleared Jun 19, 1984
MAC LEE VAGINAL IRRIGATOR
K841710 · HED
Mac Lee Medical Products
Obstetrics & Gynecology · 56d
Cleared Jun 19, 1984
WOODLYN CLASSIC INSTRUMENT STAND
K841760 · HRJ
Woodlyn, Inc.
Ophthalmic · 53d
Cleared Jun 19, 1984
OBSTETRICAL DOPPLER
K841805 · KNG
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 49d
Cleared Jun 19, 1984
AMER. MED. OPTICS ARGON LASER PHOTO
K841855 · HQF
American Medical Optics
Ophthalmic · 47d
Cleared Jun 19, 1984
6.5MM HEX HANDLE
K841969 · LXH
Stainless Mfg., Inc.
Orthopedic · 36d
Cleared Jun 19, 1984
CAMELBACK HANDLE-K841969-LABELING
K841970 · LXH
Stainless Mfg., Inc.
Orthopedic · 36d