FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75145–75168 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2002
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
K020475 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 143d
Cleared Jul 05, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS
K020818 · LYY
Allegiance Healthcare Corp.
General Hospital · 114d
Cleared Jul 05, 2002
ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE...
K021007 · LYY
Tillotson Healthcare Corp.
General Hospital · 99d
Cleared Jul 05, 2002
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING...
K021119 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 88d
Cleared Jul 05, 2002
DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A
K021179 · OCY
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 81d
Cleared Jul 05, 2002
ULTRASONIC TIPS WITH DIAMOND COATING
K021253 · ELC
Sybron Endo/Analytic
Dental · 77d
Cleared Jul 05, 2002
EMBRYO BIOPSY MEDIUM
K021358 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 67d
Cleared Jul 05, 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · JFY
Bayer Corp.
Chemistry · 63d
Cleared Jul 05, 2002
GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE)
K021730 · LZA
Glovco (M) Sdn. Bhd.
General Hospital · 42d
Cleared Jul 05, 2002
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
K022018 · LJM
Rhigene, Inc.
Immunology · 15d
Cleared Jul 03, 2002
BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
K002741 · JOJ
Albert Browne , Ltd.
General Hospital · 670d
Cleared Jul 03, 2002
CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
K012600 · NLF
Clearmedical, Inc.
Anesthesiology · 324d
Cleared Jul 03, 2002
CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
K012609 · NLF
Clearmedical, Inc.
Anesthesiology · 324d
Cleared Jul 03, 2002
CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
K012622 · NLF
Clearmedical, Inc.
Anesthesiology · 324d
Cleared Jul 03, 2002
POWERED MUSCLE STIMULATOR
K013768 · IPF
Theratech, Inc.
Physical Medicine · 232d
Cleared Jul 03, 2002
FIBIOCORE
K020431 · ELR
Est. Anthogyr
Dental · 145d
Cleared Jul 03, 2002
CARESIDE LDH
K020484 · CFH
Careside, Inc.
Chemistry · 140d
Cleared Jul 03, 2002
POLY-CHEM GLUCOSE
K020852 · CFR
Polymedco, Inc.
Chemistry · 110d
Cleared Jul 03, 2002
LIGHT SABER SPINAL NEEDLE
K021084 · FMF
Minrad, Inc.
Radiology · 90d
Cleared Jul 03, 2002
INTROCAN SAFETY IV CATHETER
K021094 · DYB
B.Braun Medical, Inc.
Cardiovascular · 90d
Cleared Jul 03, 2002
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
K021159 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 83d
Cleared Jul 03, 2002
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
K021261 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 75d
Cleared Jul 03, 2002
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC...
K021332 · CGS
Wiener Laboratories Saic
Chemistry · 68d
Cleared Jul 03, 2002
AART PECTORALIS IMPLANT
K021337 · MIC
Aesthetic and Reconstructive...
General & Plastic Surgery · 68d