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
72841–72864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2002
BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES
K022091 · LYZ
Tangshan Zhonghong Pulin Group Co., Ltd.
General Hospital · 186d
Cleared Dec 30, 2002
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
K022584 · MGQ
Cardiotech Intl.
General & Plastic Surgery · 147d
Cleared Dec 30, 2002
ACELL UBM HYDRATED WOUND DRESSING
K022854 · KGN
Acell, Inc.
General & Plastic Surgery · 137d
Cleared Dec 30, 2002
ULTRA-LITE 200E LIGHT CURE UNIT
K023545 · EBZ
Rolence Ent., Inc.
Dental · 69d
Cleared Dec 30, 2002
SICKLE-CHEX SOLUBILITY KIT
K023656 · GHM
Streck Laboratories, Inc.
Hematology · 61d
Cleared Dec 30, 2002
PREPARE ADMINISTRATION SET
K023769 · FPA
Appro Healthcare, Inc.
General Hospital · 48d
Cleared Dec 30, 2002
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024032 · DQY
Medtronic Vascular
Cardiovascular · 24d
Cleared Dec 30, 2002
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
K024035 · DQY
Medtronic Vascular
Cardiovascular · 24d
Cleared Dec 30, 2002
NARROW ASCENT INTERLOK FEMORAL COMPONENTS
K024037 · JWH
Biomet, Inc.
Orthopedic · 24d
Cleared Dec 30, 2002
MODIFICATION TO CARDEON AEGIS CATHETER
K024058 · DWF
Cardeon Corp.
Cardiovascular · 21d
Cleared Dec 30, 2002
BD ULTRA-FINE III PEN NEEDLE
K024109 · FMI
Becton, Dickinson & CO
General Hospital · 17d
Cleared Dec 30, 2002
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE
K024130 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 14d
Cleared Dec 27, 2002
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY
K021987 · IXI
S&S Par Scientific
Radiology · 192d
Cleared Dec 27, 2002
NON-BIOABSORBABLE STAPLE
K023372 · NJU
Onux Medical, Inc.
General & Plastic Surgery · 80d
Cleared Dec 27, 2002
MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
K023388 · JDR
Mitek Worldwide
Orthopedic · 79d
Cleared Dec 27, 2002
GALAXY SERIES WHEELCHAIR
K023993 · IOR
Evermed Corp.
Physical Medicine · 24d
Cleared Dec 26, 2002
MASTEL 1 FOLDER IMPLANTATION SYSTEM
K022723 · KYB
Mastel Precision, Inc.
Ophthalmic · 132d
Cleared Dec 26, 2002
ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12
K023222 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 26, 2002
INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200
K023259 · FDF
Helix Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Dec 26, 2002
KEGELMASTER 2000
K023305 · HIR
Kegelmaster 2000 , Ltd.
Gastroenterology & Urology · 84d
Cleared Dec 26, 2002
MODIFICATION TO ALKP
K023807 · CJE
Abbott Laboratories
Chemistry · 42d
Cleared Dec 24, 2002
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
K021509 · JOW
Hygia Health Services, Inc.
Cardiovascular · 229d
Cleared Dec 24, 2002
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
K022517 · IYN
U-Systems, Inc.
Radiology · 147d
Cleared Dec 24, 2002
TELEGRAPH HUMERAL NAIL
K023241 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 85d