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
128713–128736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1989
PATIENT EXAMINATION GLOVES
K892311 · LYY
Southern Rubber Industries Co., Ltd.
General Hospital · 190d
Cleared Oct 13, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892313 · LYY
Glove Lines Private , Ltd.
General Hospital · 190d
Cleared Oct 13, 1989
ANESTHETIC AGENT MONITOR
K892854 · CBQ
Criticare Systems, Inc.
Anesthesiology · 178d
Cleared Oct 13, 1989
ENEMA KIT
K894209 · KPL
Ledins Herbal Healing Systems
Gastroenterology & Urology · 116d
Cleared Oct 13, 1989
NIPRO DENTAL NEEDLE
K894373 · DZM
Pharma-Plast USA, Inc.
Dental · 88d
Cleared Oct 13, 1989
DEVILBISS MODEL 6610D
K894441 · CCQ
Devilbiss Health Care, Inc.
Anesthesiology · 88d
Cleared Oct 13, 1989
CARNATION TRACHEOSTOMY MASKS
K894457 · BYF
Dadsun Corp., Ltd.
Anesthesiology · 87d
Cleared Oct 13, 1989
LIGHT BOND SEALANT WITH FLUORIDE
K894565 · DYH
Reliance Orthodontic Products, Inc.
Dental · 84d
Cleared Oct 13, 1989
UNIVERSAL LIGHT CABLE
K894570 · LDQ
Expanded Optics, Inc.
General & Plastic Surgery · 84d
Cleared Oct 13, 1989
MICRO-AIRE HIGH SPEED DRILL (2910-000)
K894606 · EFB
Micro-Aire Surgical Instruments, Inc.
Dental · 85d
Cleared Oct 13, 1989
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894613 · JOH
Bivona Medical Technologies
Anesthesiology · 85d
Cleared Oct 13, 1989
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894614 · JOH
Bivona Medical Technologies
Anesthesiology · 85d
Cleared Oct 13, 1989
EMERSON 33-CR CHEST RESPIRATOR
K894649 · BYT
Emerson Intl. Co.
Anesthesiology · 81d
Cleared Oct 13, 1989
LASER SHIELDING TUBE
K894669 · BTR
Vitaid, Ltd.
Anesthesiology · 81d
Cleared Oct 13, 1989
MEDIZIV EPIDURAL SYSTEMS
K894725 · CAZ
Mediziv Medical Devices, Ltd.
Anesthesiology · 80d
Cleared Oct 13, 1989
ALLPAC(TM) MATERIAL
K894759 · EIA
Barrier Concepts, Inc.
Dental · 78d
Cleared Oct 13, 1989
MYODAC2 BIOFEEDBACK DEVICE
K894840 · HCC
Thought Technology , Ltd.
Neurology · 85d
Cleared Oct 13, 1989
SRI 100 RADIOTHERAPY IMAGING SYSTEM
K894912 · IYE
Philips Medical Systems, Inc.
Radiology · 72d
Cleared Oct 13, 1989
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.
K894993 · CDP
Baxter Healthcare Corp
Toxicology · 66d
Cleared Oct 13, 1989
CONNELL-STEPHENS ENDO ANESS TUBE
K895132 · BTR
The Traumafuse Co.
Anesthesiology · 57d
Cleared Oct 13, 1989
MANUAL DISPOSABLE PULMONARY RESUSCITATOR
K895169 · BTM
F.L.W. Plastics, Inc.
Anesthesiology · 64d
Cleared Oct 13, 1989
JOHNSON & JOHNSON TUBE SECUREMENT DEVICE
K895431 · KMK
Johnson & Johnson Patient Care, Inc.
General Hospital · 37d
Cleared Oct 13, 1989
BIRD (VDR) SINUSOIDAL PERCUSSIONATORS
K895486 · CBK
Percussionaire Corp.
Anesthesiology · 32d
Cleared Oct 13, 1989
SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES
K895604 · GXY
Medical Design & Manufacturing Corp.
Neurology · 25d