FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141553–141576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 1986
DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE
K864397 · FLL
American Pharmaseal Div. Ahsc
General Hospital · 25d
Cleared Dec 01, 1986
RAIL CLAMP EXTENSION PIECE
K864459 · FWZ
American Container Technology, Inc.
General & Plastic Surgery · 19d
Cleared Dec 01, 1986
3 RING ATTACHMENT
K864555 · FMF
Professional Medical Services
General Hospital · 12d
Cleared Dec 01, 1986
AQUALUBE(TM)
K864556 · KMJ
Parker Laboratories, Inc.
General Hospital · 12d
Cleared Nov 28, 1986
AVP TELEIMAGING SYSTEM
K862158 · LMD
Advanced Video Products, Inc.
Radiology · 175d
Cleared Nov 28, 1986
ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340
K862165 · IYO
Hitachi Medical Corp. of America
Radiology · 175d
Cleared Nov 28, 1986
EBV/VCA-CHECK(TM) ANTIGEN SLIDES
K863408 · GNP
Diagnostic Technology, Inc.
Microbiology · 86d
Cleared Nov 28, 1986
CREATIVE CARE SYSTEMS' IV START KIT
K863796 · LRS
American Biomaterials Corp.
General & Plastic Surgery · 60d
Cleared Nov 28, 1986
TOXOPLASMA IGG MICROASSAY
K863813 · LGD
Diamedix Corp.
Microbiology · 59d
Cleared Nov 28, 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Nov 28, 1986
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
K863963 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 49d
Cleared Nov 28, 1986
MICRO-READER
K864060 · JJQ
Hyperion, Inc.
Chemistry · 39d
Cleared Nov 28, 1986
OPHTHALMIC SURGICAL INSTRUMENTS
K864183 · HNR
Techno Ophthalmics Intl.
Ophthalmic · 32d
Cleared Nov 28, 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K864230 · CKE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 31d
Cleared Nov 28, 1986
OPHTHALMIC KNIFE & FORCEPS
K864266 · HNR
Western Medical Products, Inc.
Ophthalmic · 30d
Cleared Nov 28, 1986
BL1 (HARD CONTACT LENS)
K864343 · HPX
Beta Labs, Inc.
Ophthalmic · 24d
Cleared Nov 28, 1986
LANDERS INDIRECT VITRECTOMY LENS
K864418 · HJK
Ocular Instruments, Inc.
Ophthalmic · 18d
Cleared Nov 28, 1986
THERMOSTABLE NUCLEASE TEST AGAR
K864454 · JSH
Dimed, Intl.
Microbiology · 16d
Cleared Nov 26, 1986
PLOTTER MODEL (MP100)
K861905
Madsen Electronics (Canada) , Ltd.
Gastroenterology & Urology · 194d
Cleared Nov 26, 1986
TELERADIOGRAPHY SYSTEM
K862744 · LMD
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 128d
Cleared Nov 26, 1986
ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+
K863176 · LYC
Coors Biomedical Co.
Dental · 100d
Cleared Nov 26, 1986
VELCOM-100
K863210 · DPW
Waters Instruments, Inc.
Cardiovascular · 98d
Cleared Nov 26, 1986
CARDS(TM) STREP A CATALOG NO. CR-7545
K863647 · GTZ
Pacific Biotech, Inc.
Microbiology · 69d
Cleared Nov 26, 1986
OMNI-FIL
K863876 · EBF
Inpromas
Dental · 51d