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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
150673–150696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 03, 1985
RAICHEM PHOSPHORUS REAGENT
K844316 · CEO
Reagents Applications, Inc.
Chemistry · 48d
Cleared Jan 03, 1985
ALBUMIN REAGENT FOR DEMAND ANALYZER
K844330 · CIX
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Jan 03, 1985
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
K844331 · CEK
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Jan 03, 1985
CREATININE REAGENT FOR DEMAND ANALYZER
K844332 · CGX
Advanced Biomedical Methods, Inc.
Chemistry · 57d
Cleared Jan 03, 1985
GEMCAL ENI REFERENCE SERUM
K844344 · JIX
Biocell Laboratories, Inc.
Chemistry · 55d
Cleared Jan 03, 1985
SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP
K844358 · HQF
Coherent Medical Group
Ophthalmic · 55d
Cleared Jan 03, 1985
ND:YAG LASER PULMONARY OBSTRUCTION
K844458
Endo Lase, Inc.
Cardiovascular · 49d
Cleared Jan 03, 1985
HOBBS MEDICAL/JAYCO ASPIRATION CATHETER
K844550 · OCX
Hobbs Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 03, 1985
HOBBS MEDICAL /JAYCO MULTIPLE BIOPSY INSTRUMENT
K844551 · FCL
Gobbs Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 03, 1985
MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE
K844668 · HQF
Cooper Lasersonics, Inc.
Ophthalmic · 34d
Cleared Jan 03, 1985
MAGNIFYING SPECTACLES W/PLASTIC LENSES
K844716 · HOI
Gazelle Corp.
Ophthalmic · 30d
Cleared Jan 02, 1985
HYDROGLIDE SPRING GUIDE WIRES
K841926 · DQX
Argon Medical Corp.
Cardiovascular · 237d
Cleared Jan 02, 1985
FEMALE URINARY INCONTINENCE SYS
K843128 · KNX
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 146d
Cleared Jan 02, 1985
PTCA GUIDING CATHER
K844161 · DQO
Cordis Corp.
Cardiovascular · 71d
Cleared Jan 02, 1985
ENTERNAL FEEDING TUBE-POLYURETHANE EF504
K844175 · KNT
Exco, Inc.
Gastroenterology & Urology · 69d
Cleared Jan 02, 1985
ENTERNAL FEEDING TUBE SILICONE-EF401, 402 & 403
K844203 · KNT
Exco, Inc.
Gastroenterology & Urology · 64d
Cleared Jan 02, 1985
ELECTROCARDIOGRAPH ELECTRODE
K844335 · DRX
Meditect
Cardiovascular · 56d
Cleared Jan 02, 1985
CONTOUR ELECTRODE
K844345 · DRX
Heuristic Medical Systems, Inc.
Cardiovascular · 54d
Cleared Jan 02, 1985
SKIASCOPIC RACKS
K844364 · HMH
Luneau Laboratories
Ophthalmic · 50d
Cleared Jan 02, 1985
COLOR VISION TESTERS
K844365 · HIT
Luneau Laboratories
Ophthalmic · 50d
Cleared Jan 02, 1985
UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK
K844503 · FAP
Epcom Medical Systems, Inc.
Gastroenterology & Urology · 43d
Cleared Jan 02, 1985
ENDOSCOPIC MANUAL AIR INSUFFLATOR
K844689 · FCX
Jayco Pharmaceuticals
Gastroenterology & Urology · 30d
Cleared Jan 02, 1985
ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT
K844690 · FCL
Jayco Pharmaceuticals
Gastroenterology & Urology · 30d
Cleared Jan 02, 1985
ENDOSCOPIC ASPIRATION CATHETER SET
K844691 · OCX
Jayco Pharmaceuticals
Gastroenterology & Urology · 30d