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
129313–129336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1989
HAEMOPHILUS TEST MEDIUM (BROTH)
K894848 · JSO
Regional Media Laboratories
Microbiology · 37d
Cleared Sep 05, 1989
APACERAM ARTIFICIAL DENTAL IMPLANT
K885133 · DZE
Asahi Optical Co. C/O Rosati...
Dental · 267d
Cleared Sep 05, 1989
ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER
K890687 · HLQ
Optimed, Inc.
Ophthalmic · 208d
Cleared Sep 05, 1989
LATEXCO LATEX EXAMINATION GLOVES
K891265 · LYY
Latex Products Co., Inc.
General Hospital · 181d
Cleared Sep 05, 1989
GENERAL IVT NEEDLE GUIDE KIT, STERILE
K892070 · HGL
Amedic USA
Obstetrics & Gynecology · 158d
Cleared Sep 05, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892080 · LYY
The Orient Connection
General Hospital · 155d
Cleared Sep 05, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892081 · LYY
Tacare Products , Ltd.
General Hospital · 155d
Cleared Sep 05, 1989
NON-STERILE VINYL EXAMINATION GLOVES
K892994 · LYZ
Sian-Yu Industrial Co., Ltd.
General Hospital · 146d
Cleared Sep 05, 1989
LANDSCAPE PATIENT EXAMINATION GLOVES
K893049 · LYY
Pacific Intl. Economic & Technical,...
General Hospital · 145d
Cleared Sep 05, 1989
RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
K893216 · GXX
Radiation Measurements, Inc.
Neurology · 131d
Cleared Sep 05, 1989
STEALTH DILATION CATHETER SYSTEM
K893411 · LIT
Target Therapeutics
Cardiovascular · 126d
Cleared Sep 05, 1989
MYOCARDIAL PROBE THERMOMETER CODE 64000
K893418 · FLL
Dlp, Inc.
General Hospital · 126d
Cleared Sep 05, 1989
BARD CATH LAB THERMODILUTION CATHETER
K893474 · DYG
C.R. Bard, Inc.
Cardiovascular · 124d
Cleared Sep 05, 1989
OXIMETER
K893587 · DQA
Radiometer America, Inc.
Anesthesiology · 119d
Cleared Sep 05, 1989
CALCIUM TEST ITEM NUMBER: 65409
K893778 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 106d
Cleared Sep 05, 1989
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER
K893963 · DSB
V.S.B.B. Technologies, Inc.
Cardiovascular · 95d
Cleared Sep 05, 1989
PATIENT EXAMINATION GLOVES
K894003 · LYY
Beekay Hygiene Products
General Hospital · 92d
Cleared Sep 05, 1989
ROCHE REAGENT FOR URIC ACID
K894101 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Sep 05, 1989
EMIT T-UPTAKE ASSAY
K894145 · KHQ
Syva Co.
Chemistry · 83d
Cleared Sep 05, 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K894146 · JWY
Baxter Healthcare Corp
Microbiology · 83d
Cleared Sep 05, 1989
MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL
K894148 · JDI
Howmedica Corp.
Orthopedic · 83d
Cleared Sep 05, 1989
BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT
K894173 · CDQ
Catachem, Inc.
Chemistry · 82d
Cleared Sep 05, 1989
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
K894317 · JOX
Hemotec, Inc.
Hematology · 53d
Cleared Sep 05, 1989
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
K894329 · JJX
Amersham Corp.
Chemistry · 53d