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
100489–100512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1995
I-SPOUSE
K953089 · LYU
Products For Medicine
General Hospital · 105d
Cleared Oct 16, 1995
SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS
K953351 · CCL
Seatronics Co.
Anesthesiology · 91d
Cleared Oct 16, 1995
LAPAROSCOPIC TROCAR
K953409 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 88d
Cleared Oct 16, 1995
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
K953691 · EZN
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 69d
Cleared Oct 16, 1995
ERBOTOM ICC 300
K953738 · GEI
Erbe Electromedizin GmbH
General & Plastic Surgery · 67d
Cleared Oct 16, 1995
HUMIDIFIER & ACCESSORIES
K953949 · CAW
Fisher & Paykel Electronics , Ltd.
Anesthesiology · 55d
Cleared Oct 16, 1995
G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO...
K954041 · FMI
Glaxo, Inc.
General Hospital · 48d
Cleared Oct 16, 1995
SODEM HIGH SPEED SYSTEM
K954080 · HSZ
Sodem Diffusion SA
Orthopedic · 46d
Cleared Oct 16, 1995
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
K954273 · JHI
Quidel Corp.
Chemistry · 33d
Cleared Oct 16, 1995
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
K954384 · MGQ
Renaissance Pharmaceutical, Inc.
General & Plastic Surgery · 27d
Cleared Oct 16, 1995
AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE
K954461 · EBF
American Dental Products, Inc.
Dental · 21d
Cleared Oct 16, 1995
MICROSURGE VERESS NEEDLE
K954520 · HET
Microsurge, Inc.
Obstetrics & Gynecology · 18d
Cleared Oct 13, 1995
REGULUS MEASUREMENT UNIT
K935456 · HAW
Compass Intl., Inc.
Radiology · 700d
Cleared Oct 13, 1995
PAIN DOC
K941342 · GZB
Regulatory & Marketing Services, Inc.
Neurology · 598d
Cleared Oct 13, 1995
QTMICRO(TM) SYSTEM
K950305 · LHI
Q.I. Medical, Inc.
General Hospital · 261d
Cleared Oct 13, 1995
SMART WAVE GS100
K950617 · IPF
Shotwell & Carr, Inc.
Physical Medicine · 245d
Cleared Oct 13, 1995
CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
K951363 · MID
Immunoprobe, Inc.
Immunology · 203d
Cleared Oct 13, 1995
COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
K951639 · DAE
Incstar Corp.
Immunology · 186d
Cleared Oct 13, 1995
TRACE COBAS MIRA RANGE
K952488 · CIX
Trace Scientific , Ltd.
Chemistry · 136d
Cleared Oct 13, 1995
DELWA-STAR PACIFIER THERMOMETER
K952765 · FLL
Zewa, Inc.
General Hospital · 162d
Cleared Oct 13, 1995
PRECISIONIST THIRTY THOUSAND
K953447 · HQC
Paradigm Medical Industries, Inc.
Ophthalmic · 88d
Cleared Oct 13, 1995
ROCHE COBAS MICROS HEMATOLOGY ANALYZER
K953448 · GKZ
Roche Diagnostic Systems, Inc.
Hematology · 88d
Cleared Oct 13, 1995
RUSCH TRACHEAL BRONCHIAL Y STENT
K953593 · NYT
Rusch, Inc.
General & Plastic Surgery · 74d
Cleared Oct 13, 1995
J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS
K953655 · OCX
Johnson & Johnson Medical, Inc.
Gastroenterology & Urology · 70d