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
129793–129816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1989
GAMMAMED 12I
K891131 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 157d
Cleared Aug 07, 1989
GERBER PRECIOUS CARE ELECTRIC BREAST PUMP
K891996 · HGX
Gerber Products Co.
Obstetrics & Gynecology · 132d
Cleared Aug 07, 1989
MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION
K892884 · GZB
Medtronic Vascular
Neurology · 110d
Cleared Aug 07, 1989
VECSEI EXPANDING SCREW
K892925 · HWC
Howmedica Corp.
Orthopedic · 108d
Cleared Aug 07, 1989
MATRX DENTAL UNIT
K893219 · EIA
Matrix Medica, Inc.
Dental · 102d
Cleared Aug 07, 1989
CT SYTEC 3000
K893820 · JAK
General Electric Co.
Radiology · 76d
Cleared Aug 07, 1989
HOOD PEDIATRIC TRACHEOSTOMY TUBE
K893866 · BTO
Hood Laboratories
Anesthesiology · 73d
Cleared Aug 07, 1989
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K893938 · CAZ
Medsurg Industries, Inc.
Anesthesiology · 68d
Cleared Aug 07, 1989
#157 EXAM LIGHT
K893949 · KFK
Medmark, Inc.
General & Plastic Surgery · 67d
Cleared Aug 07, 1989
LATEX EXAMINATION GLOVES
K894014 · LYY
Hsin Hung Co. , Ltd.
General Hospital · 62d
Cleared Aug 07, 1989
THE PUDENZ IN LINE VALVE
K894072 · JXG
Baxter Healthcare Corp
Neurology · 60d
Cleared Aug 07, 1989
NIDEK MODEL AKC-8000
K894273 · HQF
Nidek, Inc.
Ophthalmic · 46d
Cleared Aug 07, 1989
OXYGEN THERAPY REGULATOR
K894302 · CAN
Modern Engineering Co., Inc.
Anesthesiology · 96d
Cleared Aug 07, 1989
SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER
K894396 · GEX
Surgilase, Inc.
General & Plastic Surgery · 21d
Cleared Aug 07, 1989
LIGHTSCOPE SET
K894557 · HRW
Optik
Neurology · 18d
Cleared Aug 07, 1989
MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SET
K894558 · HRX
Optik
Orthopedic · 18d
Cleared Aug 04, 1989
PROWESS 2000
K884261 · KPQ
Small Systems Group, Inc.
Radiology · 297d
Cleared Aug 04, 1989
TRT (ACUSON) NEEDLE GUIDE KIT, STERILE
K892068 · FCG
Amedic USA
Gastroenterology & Urology · 127d
Cleared Aug 04, 1989
QUICKPAD (ALCOHOL SWABS)
K892193 · LKB
Holtsch Co., Inc.
General Hospital · 121d
Cleared Aug 04, 1989
NON-STERILE PATIENT EXAMINATION GLOVES
K892772 · LYY
Care-Pro Industries, Inc.
General Hospital · 113d
Cleared Aug 04, 1989
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · CBK
Puritan Bennett Corp.
Anesthesiology · 102d
Cleared Aug 04, 1989
EASY BREATHER MODEL 100
K893213 · BYT
Progressive Productions , Ltd.
Anesthesiology · 99d
Cleared Aug 04, 1989
PERSONAL AMPLIFIER RECHARGEABLE MODEL TRIUMPH II
K893432 · ESD
Electone, Inc.
Ear, Nose, Throat · 94d
Cleared Aug 04, 1989
PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
K893508 · JFH
Baxter Healthcare Corp
Pathology · 91d