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
157105–157128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1983
AXCAN SPERM CUP
K831669 · HDR
Axcan Scientific Corp.
Obstetrics & Gynecology · 50d
Cleared Jul 12, 1983
STRESS MACHINE
K831699 · ISA
Dr. William F. Curran
Physical Medicine · 48d
Cleared Jul 12, 1983
UNIVERSAL PACK
K831701 · HQC
Atlantic Optical Systems, Inc.
Ophthalmic · 48d
Cleared Jul 12, 1983
ELECTRONIC CLINICAL THERMOMETER
K831718 · FLL
Mitteloy
General Hospital · 42d
Cleared Jul 12, 1983
ENDODONTIC ROOT CANAL PLUGGER FINGER-
K831748 · EKR
Union Branch
Dental · 50d
Cleared Jul 12, 1983
ENDODONTIC BROACH(76EKN) BARBED BROACH
K831749 · EKW
Union Branch
Dental · 50d
Cleared Jul 12, 1983
HERAPIN LOCK FLUSH SOLUTION USE KIT
K831765 · FMI
Smith & Nephew, Mpl Division
Hematology · 41d
Cleared Jul 12, 1983
DOBBHOFF FEEDING TUBE W/HYDROMER LUB
K831868 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 32d
Cleared Jul 12, 1983
COMPUTERIZED TOMOGRAPHY-HYPERBARIC OXYG
K831888 · HST
Portable Travtion Device Co.
Neurology · 29d
Cleared Jul 12, 1983
LACIMAL INTUBATION SETS
K831901 · HNL
Visitec Co.
Ophthalmic · 28d
Cleared Jul 12, 1983
STRYKER LEG EXERCISER
K831910 · BXB
Stryker Corp.
Physical Medicine · 28d
Cleared Jul 12, 1983
DISPOSABLE CYSTOTOME
K831916 · HNY
CooperVision, Inc.
Ophthalmic · 28d
Cleared Jul 12, 1983
SURGICAL APPAREL SHOE COVERS
K831952 · BWP
Sudreca Surgical Dressings, Inc.
General & Plastic Surgery · 27d
Cleared Jul 12, 1983
MICRO SURGICAL HANDLE
K831996 · KYG
Visitec Co.
Ophthalmic · 21d
Cleared Jul 12, 1983
THIGH HOLDER
K832000
Richards Manufacturer Co.
General & Plastic Surgery · 21d
Cleared Jul 12, 1983
HEAD-IMMOBILIZER
K832001 · IQK
Int'L Safety Corp.
Physical Medicine · 20d
Cleared Jul 12, 1983
NURSE CALL BUTTON
K832057 · IQA
Qa Alert Systems
Physical Medicine · 15d
Cleared Jul 12, 1983
SCENTED MENSTRUAL PAD
K832215
Personal Products Co.
Obstetrics & Gynecology · 47d
Cleared Jul 07, 1983
INDIRECT FLUORO-KIT HSV
K830623 · GQL
Clinical Sciences, Inc.
Microbiology · 129d
Cleared Jul 07, 1983
SUPPORT PRODUCTS EXAMPLE PROSET CAST
K830650 · ITG
Isopedix Corp.
Physical Medicine · 126d
Cleared Jul 07, 1983
OMAR
K830915 · DSH
Oxford Medilog, Inc.
Cardiovascular · 107d
Cleared Jul 07, 1983
VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR
K830916 · DRT
Bib, Inc.
Cardiovascular · 107d
Cleared Jul 07, 1983
OCCULT-ALERT
K830919 · KHE
Beta Med Pharmaceuticals, Inc.
Chemistry · 107d
Cleared Jul 07, 1983
ALPHA-STIM 350
K831145 · GZJ
Electromedical Products, Inc.
Neurology · 90d