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
157993–158016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1983
BINOCULAR MAGNIFIER 2X
K830774 · HKC
Almore Intl., Inc.
Ophthalmic · 26d
Cleared Apr 06, 1983
ELECTRIC MOUTH MIRROR
K830777 · EAX
Almore Intl., Inc.
Dental · 26d
Cleared Apr 06, 1983
POINT, PAPER ENDODONTIC
K830814 · KJJ
Endodent, Inc.
Dental · 22d
Cleared Apr 06, 1983
MODIFICATION ELECTRONIC CLINICAL THERMO-
K830819 · FLL
Mon-A-Therm, Inc.
General Hospital · 22d
Cleared Apr 06, 1983
EYE DRAPE
K830822 · HMT
CooperVision, Inc.
General Hospital · 22d
Cleared Apr 06, 1983
STERILE 5 IN 1 CONNECTORS
K830835 · GAZ
Abco Dealers, Inc.
General Hospital · 21d
Cleared Apr 06, 1983
AMER. 400 SERIES TEMP. PROBES-RECTALL
K830839 · FLL
American Pharmaseal Div. Ahsc
General Hospital · 21d
Cleared Apr 06, 1983
OPEN ENDED URETERAL CATHETER
K830840 · GBM
Van-Tec, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 06, 1983
BINOCULAR LOUPE
K830878 · HJH
Almore Intl., Inc.
Ophthalmic · 19d
Cleared Apr 06, 1983
CONNECTOR 5 IN 1, T-CONNECTOR
K830901 · GAZ
Medical Specialists IN Packaging
General Hospital · 16d
Cleared Apr 06, 1983
LUNDIA 10-2-N PARALLEL FLOW DIALYZER
K830905 · KOC
Gambro, Inc.
Gastroenterology & Urology · 16d
Cleared Apr 05, 1983
HERPES-IHA KIT
K822095 · KLC
Hillcrest Biologicals
Microbiology · 263d
Cleared Apr 05, 1983
PHADEBAS HUMYLASE CONTROL(H)
K823421 · JJX
Pharmacia, Inc.
Chemistry · 138d
Cleared Apr 05, 1983
ELISA PLUS SYSTEM
K830212 · JJE
William-Palmer Industries, Inc.
Chemistry · 71d
Cleared Apr 05, 1983
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM
K830213 · JFP
Nova Biomedical Corp.
Chemistry · 71d
Cleared Apr 05, 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA
K830239 · CHH
Emd Chemicals, Inc.
Chemistry · 70d
Cleared Apr 05, 1983
ULTRA CHEM BUN-UV #65080-65081
K830241 · CDQ
Emd Chemicals, Inc.
Chemistry · 70d
Cleared Apr 05, 1983
YEAST IDENT
K830286 · JXB
Analytical Products, Inc.
Microbiology · 68d
Cleared Apr 05, 1983
ACTIVAT-PARTIAL THROMBO-PLASTIN
K830320 · GGW
Helena Laboratories
Hematology · 64d
Cleared Apr 05, 1983
LIQUID THROMBOPLASTIN REAGENT
K830331 · GJS
Helena Laboratories
Hematology · 63d
Cleared Apr 05, 1983
PHAKO KIT
K830379 · HQC
Vxtra Corp.
Ophthalmic · 60d
Cleared Apr 05, 1983
IRRIGATION/ASPIRATION KIT
K830385 · HQC
Vxtra Corp.
Ophthalmic · 60d
Cleared Apr 05, 1983
RADIOIMMUNOASSAY TEST SYSTEM PRL
K830412 · CFT
Monobind
Chemistry · 56d
Cleared Apr 05, 1983
HANDPIECE SYSTEM I/A
K830413 · HQZ
Uxtra Corp.
Ophthalmic · 56d