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
132721–132744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1989
SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT
K884401 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 85d
Cleared Jan 12, 1989
NAMIC DUAL BACKCHECK VALVE
K884408 · DTL
North American Instrument Corp.
Cardiovascular · 85d
Cleared Jan 12, 1989
DOPCORD PPG
K884451 · JOM
Huntleigh Technology, Inc.
Cardiovascular · 80d
Cleared Jan 12, 1989
HEAD HOLDING DEVICE/SLEEP APNEA
K884493 · IWY
X-Ray Systems
Radiology · 78d
Cleared Jan 12, 1989
USCI ADJUSTABLE TIP GUIDE WIRE
K884647 · DQX
C.R. Bard, Inc.
Cardiovascular · 66d
Cleared Jan 12, 1989
ROCKET FETAL BLOOD SAMPLING TRAY
K884685 · HGW
A & A Medical, Inc.
Obstetrics & Gynecology · 65d
Cleared Jan 12, 1989
OPTI-POINT
K884781 · HET
Plastic Injectors, Inc.
Obstetrics & Gynecology · 58d
Cleared Jan 12, 1989
FUKUDA DENSHI MODEL FX-1201
K884992 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 42d
Cleared Jan 12, 1989
THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM
K885088 · BYH
Thayer Medical Corp.
Anesthesiology · 31d
Cleared Jan 12, 1989
MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
K885101 · DSA
Medtronic Vascular
Cardiovascular · 31d
Cleared Jan 12, 1989
MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
K885171 · DRO
Andover Medical, Inc.
Cardiovascular · 30d
Cleared Jan 11, 1989
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)
K884189 · KHP
Eastman Kodak Company
Chemistry · 98d
Cleared Jan 11, 1989
CIRCON ACMI BICAP III THERAPEUTIC SYSTEM
K884254 · KNS
Circon Acmi
Gastroenterology & Urology · 92d
Cleared Jan 11, 1989
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
K884375 · DQR
Argon Medical Corp.
Cardiovascular · 85d
Cleared Jan 11, 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 11, 1989
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
K884382 · CIW
Em Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jan 11, 1989
BETA 90/50 MOBILE IMAGING TABLE
K884531 · IXR
Beta Medical Products Co.
Radiology · 75d
Cleared Jan 11, 1989
RELIANT OXYGEN CONCENTRATOR
K884581 · CAW
Airsep Corp.
Anesthesiology · 70d
Cleared Jan 11, 1989
ALBUMIN TEST (ALB) ITEM #65650
K884705 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Jan 11, 1989
CHLORIDE TEST (CL) ITEM #65659
K884706 · CHJ
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Jan 11, 1989
MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)
K884923 · DHB
Diagnostic Products Corp.
Immunology · 47d
Cleared Jan 11, 1989
4060 HA PARTICLES
K885067 · LYC
Bio-Interfaces, Inc.
Dental · 36d
Cleared Jan 11, 1989
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · LDP
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 33d
Cleared Jan 11, 1989
LASER INDIRECT OPHTHALMOSCOPE (LIO)
K885196 · HQE
Coherent Medical Group
Ophthalmic · 26d