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
105481–105504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1994
PHOSPHORUS TEST (PHOS)
K945368 · CEO
Emd Chemicals, Inc.
Chemistry · 43d
Cleared Nov 30, 1994
DISPOSABLE BACTERIAL BREATHNG FILTER
K915750 · CAH
Hospitak, Inc.
General Hospital · 1077d
Cleared Nov 30, 1994
REUSABLE MENSTRUAL PAD
K924502 · HHD
Keema and Co.
Obstetrics & Gynecology · 817d
Cleared Nov 30, 1994
PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM
K930771 · JDI
Orthomet, Inc.
Orthopedic · 652d
Cleared Nov 30, 1994
LAPAROVIEW
K931065 · HET
Northgate Technologies, Inc.
Obstetrics & Gynecology · 639d
Cleared Nov 30, 1994
MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K936181 · FLE
Midmark Corp.
General Hospital · 338d
Cleared Nov 30, 1994
DELUXE MAGMAG BREAST PUMP
K936309 · HGX
Pigeon Corp.
Obstetrics & Gynecology · 394d
Cleared Nov 30, 1994
ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903
K940079 · DYB
Arrow Intl., Inc.
Cardiovascular · 327d
Cleared Nov 30, 1994
ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE...
K940302 · DSA
Arbo Medical, Inc.
Cardiovascular · 310d
Cleared Nov 30, 1994
DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER
K941488 · EZL
Medical Technology Development Corp.
Gastroenterology & Urology · 247d
Cleared Nov 30, 1994
OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES
K942338 · FDT
Olympus Corp.
Gastroenterology & Urology · 198d
Cleared Nov 30, 1994
COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC
K942947 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 160d
Cleared Nov 30, 1994
KULTSURE STARSWAB (M210), MODIFICATION
K943498 · JSM
Ncs Diagnostics, Inc.
Microbiology · 170d
Cleared Nov 30, 1994
KULTSURE STARSWAB(M240), MODIFICATION
K943499 · JSM
Ncs Diagnostics, Inc.
Microbiology · 170d
Cleared Nov 30, 1994
SURGICAL CUTTING BURS
K943540 · DZJ
Stryker Corp.
Dental · 131d
Cleared Nov 30, 1994
SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER
K943622 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 126d
Cleared Nov 30, 1994
LATEX EXAMINATION GLOVES
K943707 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 121d
Cleared Nov 30, 1994
ACOUSTIC RECORDER
K943726 · DQC
Technology Applications Assoc., Inc.
Cardiovascular · 120d
Cleared Nov 30, 1994
PROCHEM CHEMISTRY ANALYZER
K944028 · JJE
Prisma Systems
Chemistry · 105d
Cleared Nov 30, 1994
CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS
K944087 · DIO
Beckman Instruments, Inc.
Toxicology · 148d
Cleared Nov 30, 1994
MODEL E278OR-ASP SERIES RETRACTABLE
K944244 · GEI
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Nov 30, 1994
OKTAS STEREO VIEWING SYSTEM
K944254 · FET
Oktas
Gastroenterology & Urology · 91d
Cleared Nov 30, 1994
VARIOUS STETHOSCOPES
K944337 · LDE
Rud Riester GmbH & CO KG
Cardiovascular · 85d
Cleared Nov 30, 1994
DOCUMENT R AMMONIA/ETHANOL CONTROL
K944361 · JJX
Casco Standards
Chemistry · 84d