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
88273–88296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1998
ALBATECH PERSONAL MONITOR
K981999 · GCJ
Albatech, Inc.
General & Plastic Surgery · 88d
Cleared Sep 04, 1998
STOCKERT COMPACT SYSTEM
K982014 · DTQ
Stoeckert Instrumente
Cardiovascular · 88d
Cleared Sep 04, 1998
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
K982023 · DAS
Inova Diagnostics, Inc.
Immunology · 87d
Cleared Sep 04, 1998
HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100...
K982025 · MKJ
Hewlett-Packard Co.
Cardiovascular · 87d
Cleared Sep 04, 1998
AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
K982088 · DZB
Ortho Kinetics Corp.
Dental · 81d
Cleared Sep 04, 1998
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5...
K982102 · MEB
Baxter Healthcare Corp
General Hospital · 81d
Cleared Sep 04, 1998
FLUID CONTROL
K982117 · EIA
T.A. Coleman Ent.
Dental · 80d
Cleared Sep 04, 1998
FLOW 7000 PERIPHERAL VASCULAR COIL
K982339 · MOS
Usa Instruments, Inc.
Radiology · 60d
Cleared Sep 04, 1998
NIM4
K982595 · ETN
Xomed, Inc.
Ear, Nose, Throat · 39d
Cleared Sep 04, 1998
COLLEAGUE PUMP SYRINGE ADAPTER SET
K982672 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Sep 04, 1998
MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4
K982841 · LFL
Misonix, Inc.
General & Plastic Surgery · 23d
Cleared Sep 04, 1998
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER
K982883 · DQY
Medtronics Interventional Vascular
Cardiovascular · 18d
Cleared Sep 03, 1998
N-ASSAY GLU-UL
K980883 · CFR
Crestat Diagnostics, Inc.
Chemistry · 178d
Cleared Sep 03, 1998
SYSTEM U3 FOR CIPROFLOXACIN
K981639 · JWY
Ab Biodisk
Microbiology · 118d
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG
K981644 · MST
The Binding Site, Ltd.
Immunology · 118d
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
K981929 · MST
The Binding Site, Ltd.
Immunology · 118d
Cleared Sep 03, 1998
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
K981973 · JKA
Ram Scientific
Chemistry · 90d
Cleared Sep 03, 1998
ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU)...
K981981 · GEI
Boston Scientific Corp
General & Plastic Surgery · 90d
Cleared Sep 03, 1998
VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER
K981994 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 87d
Cleared Sep 03, 1998
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
K982089 · LFR
Boehringer Mannheim Corp.
Chemistry · 80d
Cleared Sep 03, 1998
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
K982491 · JKR
Sangui Biotech, Inc.
Chemistry · 48d
Cleared Sep 03, 1998
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K982709 · MHJ
Alexon - Trend, Inc.
Microbiology · 30d
Cleared Sep 02, 1998
MEDSCI 3% GLUTARALDEHYDE
K974062 · MED
Medsci, Inc.
General Hospital · 310d
Cleared Sep 02, 1998
ACQPLAN
K974770 · MUJ
Philips Medical Systems (Cleveland),...
Radiology · 254d