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
111985–112008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1993
B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM
K926251 · IYO
Biovision, Inc.
Radiology · 274d
Cleared Sep 14, 1993
ORALIX DC
K931001 · EHD
Gendex Corp.
Radiology · 200d
Cleared Sep 14, 1993
DISPOSABLE PEEL-AWAY INTRODUCER SHEATH
K931973 · GWG
Neuro Navigational Corp.
Neurology · 145d
Cleared Sep 13, 1993
THE BRANEMARK SYSTEM BALL ATTACHMENT ABUTMENT SYST
K920452 · DZE
Nobelpharma USA, Inc.
Dental · 587d
Cleared Sep 13, 1993
NITANIUM PALATAL EXPANDER
K923218 · EJF
Ortho Organizers, Inc.
Dental · 439d
Cleared Sep 13, 1993
PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEM
K924731 · FYD
Buffalo Filter Co., Inc.
General Hospital · 356d
Cleared Sep 13, 1993
PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM
K924732 · FYD
Buffalo Filter Co., Inc.
General Hospital · 356d
Cleared Sep 13, 1993
PLASTIC CHAIN
K925012 · EJF
American Orthodontics
Dental · 346d
Cleared Sep 13, 1993
RELAX-O-GUARD
K925064 · KMY
Aquatemp Service Co., Inc.
Dental · 342d
Cleared Sep 13, 1993
ZEISS DIODE-PUMPED SOLID STATE LASER
K925642 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 308d
Cleared Sep 13, 1993
ACUFEX SURETAC(R) PAC
K930538 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 223d
Cleared Sep 13, 1993
SANITAS PATIENT LIFT
K930625 · FSA
Dutton-Lainson Co.
General Hospital · 217d
Cleared Sep 13, 1993
ULTRA COMPACT VIDEO IMAGER
K930765 · JAK
International Imaging Electronics
Radiology · 213d
Cleared Sep 13, 1993
CLEANLET, CLEANLET XL & KIDS
K931827 · FMK
Gainor Medical Europe, Ltd.
General & Plastic Surgery · 158d
Cleared Sep 13, 1993
ION-IMPLANTED NEO SENTALLOY
K932025 · EJF
Gac Intl., Inc.
Dental · 140d
Cleared Sep 13, 1993
AMELOGEN RESTORATIVE MATERIALS
K932227 · EBF
Ultradent Products, Inc.
Dental · 129d
Cleared Sep 13, 1993
PULPDENT 2.5% NITRIC ACID ETCHANT
K932793 · EBF
Pulpdent Corp.
Dental · 96d
Cleared Sep 13, 1993
ABDOMINAL FLUID CONTROL POUCH, 203-301-S
K932857 · KKX
Ansley Medical Products, Inc.
General Hospital · 95d
Cleared Sep 13, 1993
ONE-HANDED ENDOPOUCH SPECIMEN RETRIEVAL BAG
K933104 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 80d
Cleared Sep 13, 1993
AESCULAP TROCAR INSTRUMENT SET
K933201 · GCS
Aesculap, Inc.
Gastroenterology & Urology · 74d
Cleared Sep 13, 1993
SCD(R) CONTROLLER
K933259 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 69d
Cleared Sep 10, 1993
1ST IMPRESSION
K921571 · ELW
Wykle Research, Inc.
Dental · 526d
Cleared Sep 10, 1993
PORT ACCESS INFUSION SET
K921901 · FRN
Kawasumi Laboratories Co., Ltd.
General Hospital · 506d
Cleared Sep 10, 1993
PRO-SCOPE MODEL # PS-4000
K922942 · EIA
Pro-Den Systems, Inc.
Dental · 449d