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
110521–110544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1994
DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
K934465 · BTR
Smiths Industries Medical Systems, Inc.
Anesthesiology · 123d
Cleared Jan 14, 1994
9750 ATHENA ETHERNET OPTION
K934887 · DXK
S & W Medico Teknik A/S
Cardiovascular · 94d
Cleared Jan 14, 1994
9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
K934988 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 88d
Cleared Jan 14, 1994
FONIX 3500 HEARING AID ANALYZER
K935400 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 66d
Cleared Jan 14, 1994
MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
K935553 · BSY
Puritas Health Care, Inc.
Anesthesiology · 58d
Cleared Jan 14, 1994
TUBE, INHALER OXYGEN
K935582 · BZO
Puritas Health Care, Inc.
Anesthesiology · 57d
Cleared Jan 14, 1994
DOUBLE TRACH SWIVEL CONNECTOR
K935821 · BZA
Nutec, Inc.
Anesthesiology · 42d
Cleared Jan 14, 1994
NON-WOVEN SPONGE
K935931 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
BURN COMPRESS
K935932 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
CUSTOM BURN DRESSING
K935933 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
BURN GAUZE PADS
K935935 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
CONFORMING ROLL
K935936 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
POST OP SPONGE
K935937 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS
K935938 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
GAUZE FLUFF
K935939 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
GAUZE SPONGE
K935940 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 14, 1994
READY CUT GAUZE GAUZE BOLTS
K935941 · EFQ
Mcneil Healthcare, Inc.
General & Plastic Surgery · 32d
Cleared Jan 13, 1994
SCOLE 300 ECG RECORDER
K923664 · DSH
Scole Engineering Co.
Cardiovascular · 540d
Cleared Jan 13, 1994
REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)
K925385 · JIX
Alko Diagnostic Corp.
Chemistry · 444d
Cleared Jan 13, 1994
CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR
K925464 · JIX
Alko Diagnostic Corp.
Chemistry · 441d
Cleared Jan 13, 1994
ALKO FLUIDS PACKS FOR NOVA ANALYZERS
K930199 · JIX
Alko Diagnostic Corp.
Toxicology · 364d
Cleared Jan 13, 1994
ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS
K930231 · JIX
Alko Diagnostic Corp.
Chemistry · 359d
Cleared Jan 13, 1994
ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
K930796 · JZX
Alko Diagnostic Corp.
Immunology · 331d
Cleared Jan 13, 1994
POWDER FREE LATEX EXAMINATION GLOVES
K931521 · LYY
Pt. Abbergummi Medical
General Hospital · 293d