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
154657–154680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1983
MONITORING SYSTEM AS100-AS115 RECORD
K832754 · DSF
Air-Shields, Inc.
Cardiovascular · 128d
Cleared Dec 22, 1983
PRE-GELLED DISPOS ELECTRODE
K832877 · DRX
Advance Tech Intl.
Cardiovascular · 118d
Cleared Dec 22, 1983
ACUTE HEMODIALYSIS TRAYS
K833139 · KNZ
Intermed, Inc.
Gastroenterology & Urology · 99d
Cleared Dec 22, 1983
BIOMET BIPOLAR PROSTHESIS
K833175 · KWY
Biomet, Inc.
Orthopedic · 94d
Cleared Dec 22, 1983
LOW PROFILE STEERABLE-INTRAOPERATIVE
K833248 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 98d
Cleared Dec 22, 1983
RX IV PENTRON IV
K833285 · EIS
Genesis Industries, Inc.
Dental · 91d
Cleared Dec 22, 1983
ACLAIM-QAP IBM PERSONAL COMPUTER EDT
K833353 · JQP
American Dade
Chemistry · 85d
Cleared Dec 22, 1983
KNEE PROSTHESIS-PATELLA COMPONENT
K833411 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 83d
Cleared Dec 22, 1983
PERI MIRROR/SALIVA EJECTOR
K833429 · EAX
Dentec, Inc.
Dental · 78d
Cleared Dec 22, 1983
EPOS CHEMISTRY ANALYZER 5060 & 6410
K833448 · JJE
Emd Chemicals, Inc.
Chemistry · 78d
Cleared Dec 22, 1983
RATEMINDER II SPECIALTY CARE
K833520 · LDR
Anatros Corp.
General Hospital · 72d
Cleared Dec 22, 1983
EMIT & METHOFREXATE ASSAY
K833634 · LAO
Syva Co.
Toxicology · 66d
Cleared Dec 22, 1983
KLEIN WIRE TIGHTENER/BIONIC WIRE
K833726 · HXS
Bionic Instrument Corp.
Orthopedic · 59d
Cleared Dec 22, 1983
VENOSET MULTI MED DUAL RATE PIGGYBACK
K833741 · FPA
Abbott Laboratories
General Hospital · 57d
Cleared Dec 22, 1983
EMERGENCY ASPIRATOR
K833785 · BTA
Vitalograph , Ltd.
General & Plastic Surgery · 55d
Cleared Dec 22, 1983
MICROPROCESSOR VENTILATOR 7200
K833786 · CBK
Puritan Bennett Corp.
Anesthesiology · 55d
Cleared Dec 22, 1983
HEMASTICK 1-1.5 & 2-DISPOS. BLOOD
K833816 · FMK
Medprobe Laboratories
General & Plastic Surgery · 50d
Cleared Dec 22, 1983
BACTROL TB SLIDE
K833900
Difco Laboratories, Inc.
Pathology · 38d
Cleared Dec 22, 1983
GALANTE FIBER METAL TOTAL HIP
K833912 · JDI
Zimmer, Inc.
Orthopedic · 38d
Cleared Dec 22, 1983
API STAPHASE III
K833988 · JTL
Analytical Products, Inc.
Microbiology · 34d
Cleared Dec 22, 1983
KLIGLER IRON AGAR
K834001 · JSE
Micro Media Laboratories
Microbiology · 31d
Cleared Dec 22, 1983
LYSINE IRON AGAR
K834002 · JSE
Micro Media Laboratories
Microbiology · 31d
Cleared Dec 22, 1983
MOTILITY INDOLE ORNITHINE-MEDIUM
K834003 · JSE
Micro Media Laboratories
Microbiology · 31d
Cleared Dec 22, 1983
MYCOBIOTIC AGAR
K834004 · JSE
Micro Media Laboratories
Microbiology · 31d