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
132697–132720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1989
LYME FAST TEST
K883544 · LSR
3M Company
Microbiology · 147d
Cleared Jan 13, 1989
BUCKET PROSTHESIS PORP
K883727 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 135d
Cleared Jan 13, 1989
VENTRALITH I
K883750 · DXY
Bio Pace Technology, Inc.
Cardiovascular · 134d
Cleared Jan 13, 1989
PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
K884421 · DXQ
Pymah Corp.
Cardiovascular · 85d
Cleared Jan 13, 1989
FITC MURINE MONOCLONAL ANTI-RSV IGG
K884516 · GQG
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Jan 13, 1989
FIRSTDAY EARLY PREGNANCY TESTING KIT II
K884616 · JHI
Pacific Biotech, Inc.
Chemistry · 70d
Cleared Jan 13, 1989
ACUSON I5100 ULTRASOUND TRANSDUCER
K884632 · IYO
Acuson Corp.
Radiology · 67d
Cleared Jan 13, 1989
CLINISTAT GLUCOSE REAGENT TEST
K884756 · CGA
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Jan 13, 1989
PREGNAGEN(TM)
K884880 · JHI
Biogenex Laboratories
Chemistry · 53d
Cleared Jan 13, 1989
SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
K884900 · KNW
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 51d
Cleared Jan 13, 1989
CORTRONIC SCR1000
K884911 · DSF
Cortronic Corp.
Cardiovascular · 49d
Cleared Jan 13, 1989
CALCIUM TEST ITEM NUMBER: SR1009
K884986 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
K884987 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
K884988 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Jan 13, 1989
RS-CUP ACETABULAR PROSTHESIS
K885049 · KWA
Allo Pro Corp.
Orthopedic · 37d
Cleared Jan 13, 1989
MCCONNELL REAMER GUIDE
K885100 · HTO
Mcconnell Orthopedic
Orthopedic · 32d
Cleared Jan 13, 1989
#500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES
K885199 · GEI
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 28d
Cleared Jan 13, 1989
600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE
K885200 · GEI
Olsen Electrosurgical, Inc.
General & Plastic Surgery · 28d
Cleared Jan 13, 1989
LINCOLN MILLS HIP HOLDER
K885215 · FWZ
Lincoln Mills, Inc.
General & Plastic Surgery · 25d
Cleared Jan 13, 1989
MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001
K885252 · DRQ
Ep Technologies, Inc.
Cardiovascular · 30d
Cleared Jan 13, 1989
MICROSCOPE SLIDES PRECOATED
K890042 · KEW
Stat Path
Pathology · 8d
Cleared Jan 12, 1989
SENSOCOR(TM) DIASYS
K881771 · DXN
Sensormedix, Inc.
Cardiovascular · 261d
Cleared Jan 12, 1989
CATH LAB MONITORING CATHETER
K884065 · DQO
C.R. Bard, Inc.
Cardiovascular · 108d
Cleared Jan 12, 1989
TORAY VASCULAR PROSTHESIS
K884083 · DSY
Toray Industries (America), Inc.
Cardiovascular · 107d