FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88561–88584 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 30, 1998
SEARE BIOMEDICAL SILICONE SHEETING
K983041 · MIB
Seare Biomedical Corp.
General & Plastic Surgery · 30d
Cleared Sep 30, 1998
SEARE BIOMEDICAL SILICONE BLOCK
K983043 · MIC
Seare Biomedical Corp.
General & Plastic Surgery · 30d
Cleared Sep 30, 1998
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4...
K983161 · ELR
Sabre-K , Ltd.
Dental · 21d
Cleared Sep 29, 1998
COMBISON 530D WITH POWER DOPPLER MODE
K974813 · IYN
Medison America, Inc.
Radiology · 280d
Cleared Sep 29, 1998
HYBRID CAPTURE SYSTEM CMV DNA ASSAY
K974901 · LJO
Digene Corp.
Microbiology · 272d
Cleared Sep 29, 1998
XKNIFE-4
K981055 · IYE
Radionics, Inc.
Radiology · 190d
Cleared Sep 29, 1998
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
K981306 · LGC
Diamedix Corp.
Microbiology · 172d
Cleared Sep 29, 1998
AUTOMATED MEDICAL REPORT WRITER
K981553 · KPS
Woodson and Associates, LLC
Radiology · 151d
Cleared Sep 29, 1998
PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM
K981834 · IYN
Perception, Inc.
Radiology · 126d
Cleared Sep 29, 1998
DYNAMIC SHIELDING RADIATION TABLE
K982446 · JAI
American Biophysics, Inc.
Radiology · 76d
Cleared Sep 29, 1998
LSVP INTERNATIONAL BIOPSY FORCEPS
K982983 · EOQ
Lsvp Intl., Inc.
Ear, Nose, Throat · 34d
Cleared Sep 29, 1998
PHILIPS OMNIDIAGNOST
K982993 · OWB
Philips Medical Systems, Inc.
Radiology · 33d
Cleared Sep 29, 1998
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983130 · JJY
Kamiya Biomedical Co.
Immunology · 21d
Cleared Sep 29, 1998
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
K983241 · JJY
Kamiya Biomedical Co.
Immunology · 14d
Cleared Sep 28, 1998
PGK DEVICE (MODIFIED)
K980997 · IWJ
Pgk, Inc.
Radiology · 195d