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
121273–121296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1991
MELIODENT, DENTURE RESIN
K910465 · EBI
Heraeus Kulzer, Inc.
Dental · 122d
Cleared Jun 06, 1991
SELECTOR MD (50KW AND 80 KW)
K910650 · IZO
Hofmann-Nagel Medical Systems, Inc.
Radiology · 112d
Cleared Jun 06, 1991
CINEMEASURE (TM)
K910654 · IZI
Syracuse Research Corp.
Radiology · 112d
Cleared Jun 06, 1991
MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE
K910733 · FMI
Medisystems Corp.
General Hospital · 105d
Cleared Jun 06, 1991
COMFOR-BOARD
K910880 · KMK
Medway
General Hospital · 97d
Cleared Jun 06, 1991
PROBE REFILL KIT
K911073 · ITX
Interspec, Inc.
Radiology · 87d
Cleared Jun 06, 1991
HEMOSTATIC Y CONNECTOR
K911130 · LIT
Thomas Medical Products, Inc.
Cardiovascular · 84d
Cleared Jun 06, 1991
GESCO PER-Q-CATH NEEDLE
K911215 · LIT
Gesco Intl., Inc.
Cardiovascular · 79d
Cleared Jun 06, 1991
THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2
K911246 · INX
The Medical Group, Inc.
Physical Medicine · 77d
Cleared Jun 06, 1991
HYDENT
K911259 · EFH
Pascal Co., Inc.
Dental · 76d
Cleared Jun 06, 1991
ORIGINALS
K911277 · HQY
Face 2 Face Corp.
Ophthalmic · 73d
Cleared Jun 06, 1991
ELITE SYSTEM
K911416 · LXJ
Gfb Intl. Trading, Inc.
Physical Medicine · 66d
Cleared Jun 06, 1991
I.V. EXTENDER SET
K911451 · FPB
Filtertek, Inc.
General Hospital · 64d
Cleared Jun 06, 1991
LAPAROSCOPIC RINSING CONTAINER
K911488 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 63d
Cleared Jun 06, 1991
INLAY 90
K911546 · EJT
Metalor Dental USA Corp.
Dental · 66d
Cleared Jun 06, 1991
MARK 5 ROBOTIC PIPETTOR
K912228 · JQW
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jun 05, 1991
OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP
K910989 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared Jun 04, 1991
NEUROSEARCH-24 OR NRS-24
K904269 · GWQ
Lexicor Medical Technology, Inc.
Neurology · 259d
Cleared Jun 04, 1991
POINTER F-3 TENS
K904388 · GZJ
Oms Medical Supplies, Inc.
Neurology · 252d
Cleared Jun 04, 1991
4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP
K905218 · FPA
Marquette Medical, Inc.
General Hospital · 196d
Cleared Jun 04, 1991
4' LOW VOLUME IV EXTENSION SET
K905219 · FPA
Marquette Medical, Inc.
General Hospital · 196d
Cleared Jun 04, 1991
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A
K905230 · GZJ
Biomedical Life Systems, Inc.
Neurology · 196d
Cleared Jun 04, 1991
ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A
K905377 · GZJ
Biomedical Life Systems, Inc.
Neurology · 186d
Cleared Jun 04, 1991
LITHOTRIPTOR SYSTEM MODEL 27080
K905553 · FFK
Karl Storz GmbH & Co. (Kst)
Gastroenterology & Urology · 175d