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
95617–95640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 1996
ORGENTEC ABTI-SS-BB(LA) ELISA
K962052 · LJM
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
ORGENTEC ANTI-JO-1 ELISA
K962053 · LJM
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
ORGENTEC ANTI-SS-A(RO) ELISA
K962054 · LJM
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
ORGENTEC ANTI-SCL 70 ELISA
K962055 · LJM
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
K962825 · GGP
Shield Diagnostics, Ltd.
Hematology · 119d
Cleared Nov 15, 1996
MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE
K963038 · DRX
Graphic Controls Corp.
Cardiovascular · 102d
Cleared Nov 15, 1996
SURGICAL FABRICS
K963226 · FTL
Boston Scientific Corp
General & Plastic Surgery · 88d
Cleared Nov 15, 1996
M & R DISPOSABLE ELECTRODE (14200)
K963236 · GXY
M & R Mfg., Inc.
Neurology · 88d
Cleared Nov 15, 1996
CANCELLOUS SCREW WASHER
K963420 · HTN
Orthopaedic Biosystems, Ltd.
Orthopedic · 77d
Cleared Nov 15, 1996
CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)
K963453 · FMQ
Contour Fabricators, Inc.
General Hospital · 73d
Cleared Nov 15, 1996
HYCEM APLICAP
K963737 · EMA
Espe GmbH & Co. Kg.
Dental · 59d
Cleared Nov 15, 1996
TEAM CARIES INDICATOR
K963927 · LFC
Centrix, Inc.
Dental · 66d
Cleared Nov 14, 1996
FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000
K952826 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 513d
Cleared Nov 14, 1996
FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000
K952827 · DXN
Sein Electronics Co., Ltd.
Cardiovascular · 513d
Cleared Nov 14, 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960652 · HWC
Linvatec Corp.
Orthopedic · 273d
Cleared Nov 14, 1996
B.A.S.I.C. DENTAL IMPLANT SYSTEM
K960868 · DZE
Danlin Products, Inc.
Dental · 255d
Cleared Nov 14, 1996
KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT
K961739 · LLZ
Kodak Health Imaging Systems, Inc.
Radiology · 195d
Cleared Nov 14, 1996
KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT
K961740 · LLZ
Kodak Health Imaging Systems, Inc.
Radiology · 195d
Cleared Nov 14, 1996
SYNTHES STERILE DRILL BITS
K962913 · HWE
Synthes (Usa)
Orthopedic · 111d
Cleared Nov 14, 1996
CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML)
K963215 · LJS
Bmw Medical, Inc.
General Hospital · 90d
Cleared Nov 14, 1996
STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT
K963224 · DZE
Steri-Oss, Inc.
Dental · 90d
Cleared Nov 14, 1996
ULTRAFLEX
K963241 · JCT
Boston Scientific Corp
General & Plastic Surgery · 87d
Cleared Nov 14, 1996
DURACON POSTERIOR FEMORAL SPACER
K963242 · JWH
Howmedica Corp.
Orthopedic · 87d
Cleared Nov 14, 1996
PRESSURE VALVE
K963250 · BZD
Respironics, Inc.
Anesthesiology · 87d