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
93889–93912 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1997
3M RED DOT 2560 & 2570 MONITORING ELECTRODES
K970796 · DRX
3M Healthcare
Cardiovascular · 36d
Cleared Apr 09, 1997
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
K970965 · ERL
Midas Rex Pneumatic Tools, Inc.
Ear, Nose, Throat · 23d
Cleared Apr 09, 1997
FEMTEX 100% COTTON TAMPONS
K971228 · HEB
Regu-Tech Assoc., Inc.
Obstetrics & Gynecology · 78d
Cleared Apr 08, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
K962208 · CGR
Nichols Institute Diagnostics
Chemistry · 302d
Cleared Apr 08, 1997
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
K963755 · CBP
Spiracle Technology
Anesthesiology · 202d
Cleared Apr 08, 1997
IMMULITE COCAINE METABOLITE
K963918 · DIO
Diagnostic Products Corp.
Toxicology · 190d
Cleared Apr 08, 1997
MINIMED INSULIN PUMP, MODEL 505
K963948 · LZG
Medtronic Minimed
General Hospital · 188d
Cleared Apr 08, 1997
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
K964787 · LLL
Mardx Diagnostics, Inc.
Immunology · 130d
Cleared Apr 08, 1997
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887 · LLH
Biomerieux Vitek, Inc.
Microbiology · 123d
Cleared Apr 08, 1997
NATURAL-HIP SYSTEM COCR REVISION STEM
K970166 · LZO
Intermedics Orthopedics
Orthopedic · 82d
Cleared Apr 08, 1997
IS-ANTI-SSA TEST SYSTEM
K970218 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SM TEST SYSTEM
K970220 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
K970227 · JJE
Dpc Cirrus
Microbiology · 81d
Cleared Apr 08, 1997
IS-ANTI-JO-1 TEST SYSTEM
K970228 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SSB TEST SYSTEM (720-260)
K970237 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SM/RNP (720-270)
K970238 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SCL-70 TEST SYSTEM (720-280)
K970239 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
CLINISTRIP
K970250 · JIL
Teco Diagnostics
Chemistry · 76d
Cleared Apr 08, 1997
E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
K970259 · FPA
Becton Dickinson Vascular Access, Inc.
General Hospital · 75d
Cleared Apr 08, 1997
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
K970265 · DKZ
Drial Consultants, Inc.
Toxicology · 75d
Cleared Apr 08, 1997
HYDROFLEX
K970656 · ELW
GC America, Inc.
Dental · 46d
Cleared Apr 08, 1997
CARDIOISOZYME, CK/LD ISOENZYME CONTROL
K970856 · JJT
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Apr 08, 1997
SPINALSCOPICS
K970862 · JJY
Quantimetrix Corp.
Chemistry · 32d
Cleared Apr 08, 1997
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C...
K970921 · JIX
Alko Diagnostic Corp.
Chemistry · 27d