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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
88033–88056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1998
UMECO OPTIMA 694 RUBY LASER SYSTEM
K982113 · GEX
Umeco, Inc.
General & Plastic Surgery · 106d
Cleared Sep 30, 1998
OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
K982256 · MEB
Mckinley, Inc.
General Hospital · 96d
Cleared Sep 30, 1998
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS
K982349 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Sep 30, 1998
EAGLESOFT CHAIRSIDE
K982422 · LLZ
Eaglesoft, A Patterson Co.
Radiology · 79d
Cleared Sep 30, 1998
NITRILE PATIENT EXAMINATION GLOVE
K982440 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 78d
Cleared Sep 30, 1998
TEMPFIL F - 2
K982459 · EBG
Sybron Dental Specialties, Inc.
Dental · 77d
Cleared Sep 30, 1998
EXTRACRANIAL RADIOTHERAPY SYSTEM
K982463 · IYE
Howmedica, Inc.
Radiology · 77d
Cleared Sep 30, 1998
HANDMASTER NMS1
K982482 · IPF
N.E.S.S. Nuromuscular Electrical...
Physical Medicine · 76d
Cleared Sep 30, 1998
ORTHO IMPLANT AND ACCESSORIES
K982509 · OAT
Straumann USA
Dental · 72d
Cleared Sep 30, 1998
MEDIVISION CYSTOSCOPE
K982620 · FAJ
Medivision Scope Service Center, Inc.
Gastroenterology & Urology · 65d
Cleared Sep 30, 1998
AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM
K982623 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 64d
Cleared Sep 30, 1998
JOAN II
K982648 · EFQ
Celanese Acetate Co.
General & Plastic Surgery · 63d
Cleared Sep 30, 1998
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K982704 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 58d
Cleared Sep 30, 1998
SEARE BIOMEDICAL CHIN IMPLANTS
K982752 · FWP
Seare Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Sep 30, 1998
SEARE BIOMEDICAL NASAL IMPLANTS
K982753 · FZE
Seare Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Sep 30, 1998
SEARE BIOMEDICAL PECTORALIS IMPLANT
K982762 · MIC
Seare Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Sep 30, 1998
SEARE BIOMEDICAL MALAR IMPLANTS
K982763 · LZK
Seare Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Sep 30, 1998
MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1
K982779 · EMA
Medental Intl.
Dental · 54d
Cleared Sep 30, 1998
DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER
K982781 · MMK
Thermal Waste Technology, Inc.
General Hospital · 54d
Cleared Sep 30, 1998
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982806 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 50d
Cleared Sep 30, 1998
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982807 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 50d
Cleared Sep 30, 1998
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON...
K982822 · CAK
Baxter Healthcare Corp
General Hospital · 50d
Cleared Sep 30, 1998
ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE
K982868 · JWY
Ab Biodisk
Microbiology · 47d
Cleared Sep 30, 1998
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
K982891 · DTS
California Medical Laboratories, Inc.
Cardiovascular · 44d