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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90697–90720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1998
WINGED NEEDLE HOLDER
K974327 · FHQ
Phx Technologies Corp.
Gastroenterology & Urology · 52d
Cleared Jan 09, 1998
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K974334 · LYZ
Hong Huang Tang Industrial Co., Ltd.
General Hospital · 52d
Cleared Jan 09, 1998
SUNGLASSES
K974441 · HQY
Hip Shing Fat Co., Ltd.
Ophthalmic · 45d
Cleared Jan 09, 1998
VTU-E VACUUM ERECTION SYSTEM
K974470 · LKY
Encore, Inc.
Gastroenterology & Urology · 44d
Cleared Jan 09, 1998
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
K974569 · JPA
Boehringer Mannheim Corp.
Hematology · 32d
Cleared Jan 09, 1998
SMARTVALVE
K974589 · FPA
Icu Medical, Inc.
General Hospital · 31d
Cleared Jan 09, 1998
RANDOX INORGANIC PHOSPHOROUS
K974605 · CEO
Randox Laboratories, Ltd.
Chemistry · 30d
Cleared Jan 09, 1998
MANAN(TM) SUPER-CORE BIOPSY NEEDLES
K974814 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 09, 1998
MANAN(TM) INTRODUCER SHEATH/NEEDLE
K974815 · FGE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 09, 1998
MANAN GENERAL PURPOSE INTRODUCER NEEDLE
K980004 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 7d
Cleared Jan 08, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970512 · MDB
Becton Dickinson Microbiology Systems
Microbiology · 331d
Cleared Jan 08, 1998
GLYDE DAM LOLLYES
K970577 · MSC
Glyde USA, Inc.
Obstetrics & Gynecology · 328d
Cleared Jan 08, 1998
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18,...
K971442 · KPN
Humed, Inc.
Gastroenterology & Urology · 262d
Cleared Jan 08, 1998
RUSCH BRILLANT SILICONE FOLEY CATHETER
K972184 · EZL
Rusch Intl.
Gastroenterology & Urology · 212d
Cleared Jan 08, 1998
STELA MODEL UJ45 PACING LEADS
K972574 · DTB
Ela Medical, Inc.
Cardiovascular · 182d
Cleared Jan 08, 1998
ZIPPY
K972851 · ITI
Pillar Technology, Inc.
Physical Medicine · 160d
Cleared Jan 08, 1998
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K973868 · KWP
Osteotech, Inc.
Orthopedic · 90d
Cleared Jan 08, 1998
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
K973872 · OKS
Atrion Medical Products, Inc.
Ophthalmic · 90d
Cleared Jan 08, 1998
MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES
K973887 · DQA
Masimo Corp.
Anesthesiology · 86d
Cleared Jan 08, 1998
PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D
K973983 · LLZ
Philips Medical Systems, Inc.
Radiology · 80d
Cleared Jan 08, 1998
AUTOMATED DISPOSABLE KERATOME (ADK)
K974004 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 79d
Cleared Jan 08, 1998
AMBULATORY X-12 TELEMETRY MODULE
K974149 · DRG
Mortara Instrument, Inc.
Cardiovascular · 65d
Cleared Jan 08, 1998
VISTACAM OMNI AND VIASTCAM OMNI (IC)
K974204 · EIA
Air Techniques, Inc.
Dental · 59d
Cleared Jan 08, 1998
KSEA PLASTIC TROCARS
K974366 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 49d