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
129097–129120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892466 · LYY
Zir Lih Industrial Co., Ltd.
General Hospital · 164d
Cleared Sep 18, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892610 · LYY
Pt. Indolex Karya Prakarsa
General Hospital · 161d
Cleared Sep 18, 1989
TUFFTEX PATIENT EXAM GLOVES
K892968 · LYY
Thai Latex, Inc.
General Hospital · 159d
Cleared Sep 18, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892970 · LYY
Naturub Sdn. Bhd.
General Hospital · 159d
Cleared Sep 18, 1989
CHILD SIZE - FILTER FLEX (TM)
K893030 · CAH
Life Design Systems, Inc.
General Hospital · 147d
Cleared Sep 18, 1989
LATEX EXAMINATION GLOVES
K893182 · LYY
Higlo Rubber Products Sdn. Bhd.
General Hospital · 154d
Cleared Sep 18, 1989
LATEX EXAMINATION GLOVES
K893449 · LYY
Lon Tai Chemical Industrial Co., Ltd.
General Hospital · 138d
Cleared Sep 18, 1989
AFTER LOADING DEVICE KIT
K893703 · IWJ
Medical Radiation Devices, Inc.
Radiology · 123d
Cleared Sep 18, 1989
VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000
K893716 · FPA
Baxter Healthcare Corp
General Hospital · 123d
Cleared Sep 18, 1989
PINK CASSETTE CADDIE
K893728 · IXA
Medical Technique Instruments, Inc.
Radiology · 124d
Cleared Sep 18, 1989
INAMED PRO-TEC SILICONE SURGICAL GLOVES
K894073 · KGO
Inamed Development Co.
General Hospital · 102d
Cleared Sep 18, 1989
BIOTEL MICROALBUMINURIA (TM)
K894169 · JIR
American Diagnostic Corp.
Chemistry · 95d
Cleared Sep 18, 1989
TEMP BOND NE
K894219 · EMA
Kerr Corporation (Danbury)
Dental · 91d
Cleared Sep 18, 1989
DEVILBISS MODEL 7351 SERIES
K894424 · BYE
Devilbiss Health Care, Inc.
Anesthesiology · 63d
Cleared Sep 18, 1989
MODIFIED CLAIMS FOR FEF(TM) END-TIDAL CO2 DETECTOR
K894429 · CCK
Fenem, Inc.
Anesthesiology · 63d
Cleared Sep 18, 1989
DAIG ELECTROPHYSIOLOGY CATHETER
K894500 · DRF
Daig Corp.
Cardiovascular · 61d
Cleared Sep 18, 1989
FPR THEOPHYLLINE CALIBRATOR KIT
K894530 · DLJ
Colony Laboratories, Inc.
Toxicology · 60d
Cleared Sep 18, 1989
DELFIA FREE THYROXINE (FT4) KIT
K894605 · CEC
Pharmacia, Inc.
Chemistry · 60d
Cleared Sep 18, 1989
ASC-952 PHYSIOLOGICAL AMPLIFIER
K894735 · DRR
Astro-Med, Inc.
Cardiovascular · 53d
Cleared Sep 18, 1989
T-SCOPE, TELEMETRIC PRECORDIAL STETHOSCOPE
K894757 · BZT
Louisville Laboratories, Inc.
Anesthesiology · 53d
Cleared Sep 18, 1989
ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER
K894906 · BTC
Med-Tek Corp.
Anesthesiology · 48d
Cleared Sep 18, 1989
DA-100HS
K894913 · JAA
Fischer Imaging Corp.
Radiology · 47d
Cleared Sep 18, 1989
NR5000 E.C.G. AND PULSE OXIMETER MONITOR
K894919 · DRT
Nirad , Ltd.
Cardiovascular · 47d
Cleared Sep 18, 1989
MILENIA(TM) PROLACTIN (MKPR1,5)
K895003 · CFT
Diagnostic Products Corp.
Chemistry · 41d