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
129265–129288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1989
ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
K884709 · ODD
Primrose Medical, Inc.
Gastroenterology & Urology · 304d
Cleared Sep 08, 1989
ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
K884712 · KNQ
Primrose Medical, Inc.
Gastroenterology & Urology · 304d
Cleared Sep 08, 1989
RUBENSTEIN URETERAL STONE FRAGMENT BRUSH
K885168 · FGO
Boston Scientific Corp
Gastroenterology & Urology · 269d
Cleared Sep 08, 1989
STERILE NATURAL LATEX SURGICAL GLOVES
K892108 · KGO
Ruhn Chang Industrial Co., Ltd.
General Hospital · 158d
Cleared Sep 08, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K892191 · LYZ
Hsing YI Plastics Processing Co, Ltd.
General Hospital · 156d
Cleared Sep 08, 1989
PATIENT EXAMINATION GLOVES
K893050 · LYY
Paratex Product Co., Ltd.
General Hospital · 148d
Cleared Sep 08, 1989
LATEX EXAMINATION GLOVES
K893263 · LYY
Regent Group Co., Ltd.
General Hospital · 144d
Cleared Sep 08, 1989
BIPOLAR ELECTROSURGICAL SNARE
K893553 · FDI
Everest Medical Corp.
Gastroenterology & Urology · 123d
Cleared Sep 08, 1989
LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
K893721 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 08, 1989
LORI-MODEL H, HALF CONCHA IN-THE-EAR INSTRUMENT
K893722 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 08, 1989
LORI-MODEL L, CANAL IN-THE-EAR INSTRUMENT
K893723 · ESD
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 114d
Cleared Sep 08, 1989
EPLAB (ELECTROCARDIOGRAPHIC MONITOR)
K893836 · DSH
Quinton Electrophysiology Corp.
Cardiovascular · 107d
Cleared Sep 08, 1989
PROLONG INTRAVASCULAR CATHETER
K893965 · FOZ
Baxter Healthcare Corp
General Hospital · 98d
Cleared Sep 08, 1989
NOETIX, BIOPSY NEEDLE
K893992 · KNW
Noetix, Inc.
Gastroenterology & Urology · 95d
Cleared Sep 08, 1989
IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT
K894049 · JLS
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 93d
Cleared Sep 08, 1989
GASTRO ENTEROLOGICAL BIOPTOME
K894419 · KNW
Symbiosis Corp.
Gastroenterology & Urology · 53d
Cleared Sep 08, 1989
LAMANO DIRECTORS
K894592 · GCM
Marlo Surgical Technology
Gastroenterology & Urology · 46d
Cleared Sep 08, 1989
INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM
K894612 · NHK
Intertech Resources, Inc.
Anesthesiology · 50d
Cleared Sep 08, 1989
CPAP MASK
K894690 · BYE
Devilbiss Health Care, Inc.
Anesthesiology · 46d
Cleared Sep 08, 1989
DMI SERIES 90 EXAMINATION TABLE
K894788 · KMN
M.D. Intl., Inc.
General Hospital · 42d
Cleared Sep 08, 1989
CEFIXIME 5 MCG SENSITIVITY DISKS
K894829 · JTN
Difco Laboratories, Inc.
Microbiology · 39d
Cleared Sep 08, 1989
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
K894845 · GMD
Meridian Diagnostics, Inc.
Microbiology · 28d
Cleared Sep 07, 1989
PINSET
K884970 · JKA
Safety Diagnostics, Inc.
Chemistry · 281d
Cleared Sep 07, 1989
ACUDATA INDICATENS MODEL 5M
K890087 · GZJ
Acudata Software
Neurology · 240d