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
128641–128664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1989
MILENIA(TM) TOTAL T4 (MKT41,5)
K895840 · CDP
Diagnostic Products Corp.
Chemistry · 16d
Cleared Oct 19, 1989
DELTA-TECH(TM) CAST REMOVAL SYSTEM
K895861 · LGH
Johnson & Johnson Professionals, Inc.
Orthopedic · 16d
Cleared Oct 18, 1989
AGAR 3K NEUROMUSCULAR STIMULATOR
K882386 · IPF
Solcoor, Inc.
Physical Medicine · 495d
Cleared Oct 18, 1989
COBE 2991 SUPPLEMENTARY DISPOSABLE SETS
K893962 · LKN
Cobe Laboratories, Inc.
Gastroenterology & Urology · 138d
Cleared Oct 18, 1989
COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE
K894071 · DWL
Sara Lee Corp.
General Hospital · 132d
Cleared Oct 18, 1989
2.5 FRENCH LITHOTRIPTOR ELECTRODE
K894704 · FFK
Northgate Research, Inc.
Gastroenterology & Urology · 85d
Cleared Oct 18, 1989
BIOSPOT HCG-RAPID PREGNANCY TEST
K894705 · JHI
Princeton Biomedix
Chemistry · 85d
Cleared Oct 18, 1989
BIOSTIX I. HCG - ONE STEP PREGNANCY TEST
K894750 · JHI
Princeton Biomedix
Chemistry · 84d
Cleared Oct 18, 1989
EN-TRAP SYRINGE
K895203 · FMF
The Medtech Group, Inc.
General Hospital · 61d
Cleared Oct 18, 1989
GENERAL ASPERATOR
K895761 · JCX
Kolster Methods
General & Plastic Surgery · 22d
Cleared Oct 18, 1989
CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC
K895762 · GEA
Kolster Methods
General & Plastic Surgery · 22d
Cleared Oct 18, 1989
MANAN PROSTATIC BIOPSY NEEDLE
K895897 · FCG
Manan Medical Products, Inc.
Gastroenterology & Urology · 12d
Cleared Oct 18, 1989
PRECISION DENTAL ATTACHMENTS
K895986 · EGG
Implant Support Systems, Inc.
Dental · 90d
Cleared Oct 17, 1989
EMS 300 MUSCLE STIMULATORS
K890434 · IPF
Paranamics, Inc.
Physical Medicine · 263d
Cleared Oct 17, 1989
CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
K890875 · DPS
Ppg Industries, Inc.
Cardiovascular · 238d
Cleared Oct 17, 1989
VINYL BAG W/PUMP ADMINISTRATION SET
K893540 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 162d
Cleared Oct 17, 1989
VINYL BAG W/GRAVITY ADMINISTRATION SET
K893541 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 162d
Cleared Oct 17, 1989
HOLLISTER FEEDING TUBE ATTACHMENT DEVICE
K893888 · KNT
Hollister, Inc.
Gastroenterology & Urology · 140d
Cleared Oct 17, 1989
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K894033 · DXO
Deseret Medical, Inc.
Cardiovascular · 133d
Cleared Oct 17, 1989
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
K894494 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 90d
Cleared Oct 17, 1989
WHITESIDE ORTHOLOC M.A. TIBIAL BASE
K894504 · JWH
Dow Corning Wright
Orthopedic · 90d
Cleared Oct 17, 1989
MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
K894511 · HQC
Intl. Ophthalmic Industries Corp.
Ophthalmic · 90d
Cleared Oct 17, 1989
PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS
K894512 · HQC
Intl. Ophthalmic Industries Corp.
Ophthalmic · 90d
Cleared Oct 17, 1989
RELIANCE LIGHT CURE RETAINER ACRYLIC
K894564 · EBI
Reliance Orthodontic Products, Inc.
Dental · 88d