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
145273–145296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS
K860293 · KIR
Difco Laboratories, Inc.
Pathology · 8d
Cleared Feb 05, 1986
PYR DISCS
K860302 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 8d
Cleared Feb 04, 1986
FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY
K853540 · GQX
Idt, A Division of Whittaker M.A....
Microbiology · 165d
Cleared Feb 04, 1986
HARMO SONIC
K853841 · ELC
U.S. Shizai Corp.
Dental · 141d
Cleared Feb 04, 1986
FASCILULATED NAIL
K854227 · HSB
The Deca Co.
Orthopedic · 109d
Cleared Feb 04, 1986
ASSERACHROM IX:AG
K854312 · GGP
American Bioproducts Co.
Hematology · 99d
Cleared Feb 04, 1986
CO2 LASER LAPAROSCOPE SYSTEM
K854361 · HHR
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 98d
Cleared Feb 04, 1986
ASSERACHROM FPA KIT
K854384 · DAN
American Bioproducts Co.
Hematology · 97d
Cleared Feb 04, 1986
BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER
K854466 · OLY
Biomagnetic Technologies, Inc.
Neurology · 90d
Cleared Feb 04, 1986
ORTHO HSV ANTIGEN ELISA TEST
K854488 · GQN
Ortho Diagnostic Systems, Inc.
Microbiology · 88d
Cleared Feb 04, 1986
CARDIMAX FX-406U
K854505 · DRS
Brentwood Instruments, Inc.
Cardiovascular · 84d
Cleared Feb 04, 1986
STORZ DAISY
K854508 · HQE
Storz Instrument Co.
Ophthalmic · 84d
Cleared Feb 04, 1986
UROSTAT
K854539 · KPN
Urologics, Inc.
Gastroenterology & Urology · 83d
Cleared Feb 04, 1986
MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE
K854547 · FMI
Sherwood Medical Co.
General Hospital · 83d
Cleared Feb 04, 1986
MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES
K854548 · FMI
Sherwood Medical Co.
General Hospital · 83d
Cleared Feb 04, 1986
MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU
K854549 · FMI
Sherwood Medical Co.
General Hospital · 83d
Cleared Feb 04, 1986
STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE
K854587 · HBI
Storz Instrument Co.
General & Plastic Surgery · 78d
Cleared Feb 04, 1986
INSTA-GLAZE
K854588 · EJR
George Taub Products & Fusion Co., Inc.
Dental · 78d
Cleared Feb 04, 1986
NORFOLK MEDICAL PERITONEAL-ACCESS PORT
K854593 · LMQ
Norfolk Medical Products, Inc.
General Hospital · 78d
Cleared Feb 04, 1986
PATIENTMATE TM
K854754 · FPA
Trend Medical, Inc.
General Hospital · 69d
Cleared Feb 04, 1986
SUNGLASSES
K854818 · HQY
Jarnger Trading Co., Ltd.
Ophthalmic · 63d
Cleared Feb 04, 1986
EVEREST & JENNING SERIES 5000 MODULAR BED
K854832 · FNL
Carrom Healthcare, Inc.
General Hospital · 63d
Cleared Feb 04, 1986
CYTOMEGELISA M TEST KIT
K854839 · LKQ
Whittaker Bioproducts, Inc.
Microbiology · 62d
Cleared Feb 04, 1986
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
K854851 · GTJ
Wellcome Diagnostics
Microbiology · 61d