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
134785–134808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1988
BIOTROL ALKALINE PHOSPHATASE
K881742 · CJE
Biotrol, USA, Inc.
Chemistry · 77d
Cleared Jul 08, 1988
UNSATURATED IRON BINDING CAPACITY
K881761 · JMO
Data Medical Associates, Inc.
Chemistry · 74d
Cleared Jul 08, 1988
IVORY FINDER SET
K881794 · HCY
Ivory Instruments Co.
Obstetrics & Gynecology · 73d
Cleared Jul 08, 1988
ALPINE PORTABLE OXYGEN GENERATOR
K881802 · CAW
Mountain Medical Equipment, Inc.
Anesthesiology · 71d
Cleared Jul 08, 1988
SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN
K881846 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 67d
Cleared Jul 08, 1988
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
K881852 · JJN
Helena Laboratories
Chemistry · 67d
Cleared Jul 08, 1988
ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
K881894 · GOD
Cambridge Bioscience Corp.
Microbiology · 64d
Cleared Jul 08, 1988
HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
K881907 · KHE
Enzo Biochem, Inc.
Hematology · 63d
Cleared Jul 08, 1988
PROTECTO-SHIELD
K881913 · FXX
Syntech Mfg. Services
General Hospital · 60d
Cleared Jul 08, 1988
MONOCLONAL RADIAL IMMUNODIFFUSION KIT
K881928 · CFQ
The Binding Site, Ltd.
Immunology · 60d
Cleared Jul 08, 1988
EMIT HVA CALIBRATOR KIT
K881943 · DKB
Syva Co.
Toxicology · 60d
Cleared Jul 08, 1988
EMIT HVA CONTROL KIT
K881944 · DIF
Syva Co.
Toxicology · 60d
Cleared Jul 08, 1988
LO-CORE NEEDLE
K882064 · FMI
Device Labs, Inc.
General Hospital · 52d
Cleared Jul 08, 1988
QM300 ALBUMIN ANTIBODY PACK
K882082 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 51d
Cleared Jul 08, 1988
QM300 IGG ANTIBODY PACK
K882083 · DEW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 51d
Cleared Jul 08, 1988
RESUSCITATOR VALVE ASSEMBLY W/FILTER
K882204 · CBP
Intertech/Ohio
Anesthesiology · 44d
Cleared Jul 08, 1988
WAKO(TM) CRP
K882374 · DCN
Wako Chemicals USA, Inc.
Immunology · 29d
Cleared Jul 08, 1988
KEVOR-CURETTE
K882404 · PCF
Euro-Med Intl.
Obstetrics & Gynecology · 28d
Cleared Jul 08, 1988
ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM
K882446 · DEM
Technicon Instruments Corp.
Immunology · 24d
Cleared Jul 08, 1988
REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
K882489 · BSZ
Ohmeda Medical
Anesthesiology · 22d
Cleared Jul 08, 1988
ELAN-E DISPOSALBE DRAPE
K882494 · KKX
Dermacare Products, Inc.
General Hospital · 22d
Cleared Jul 08, 1988
UNIVERSALLY ADJUSTABLE ARMBOARD
K882524 · BTX
Karlin Technology, Inc.
General & Plastic Surgery · 21d
Cleared Jul 08, 1988
RADKOR, CST-18
K882563 · IYB
Radkor, Inc.
Radiology · 17d
Cleared Jul 08, 1988
MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
K882580 · JTW
Precision Dynamics Corp.
Microbiology · 17d