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
152281–152304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1984
5MM DOUGLE EDGE RING CURETTE
K841977 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 19, 1984
LATERAL RELEASE KNIFE 5MM & 7MM
K841978 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 19, 1984
4MM CUP CURRETTE
K841979 · HTF
Stainless Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 19, 1984
4MM & 5MM FILE
K841981 · HTP
Stainless Mfg., Inc.
Orthopedic · 36d
Cleared Jun 19, 1984
MENISCOTOME 4MM & 5MM
K841982 · HTZ
Stainless Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 19, 1984
WOODLYN CLASSIC EXAM. CHAIR
K842045 · HME
Woodlyn, Inc.
Ophthalmic · 29d
Cleared Jun 19, 1984
RIM H2S
K842098 · JSF
Austin Biological Laboratories
Microbiology · 25d
Cleared Jun 19, 1984
KOGAN ENDOSPECULUM 9-1/2
K842111 · HTZ
J. Sklar Mfg. Co., Inc.
General & Plastic Surgery · 21d
Cleared Jun 19, 1984
AS LATEX PLUS
K842256 · GTQ
Biokit USA, Inc.
Microbiology · 12d
Cleared Jun 15, 1984
ENDOSCANN
K831212 · HFF
Axcan Scientific Corp.
Obstetrics & Gynecology · 428d
Cleared Jun 15, 1984
AUTOMATED NON-INVASIVE PRESSURE MODULE
K840909 · DXN
Gould, Inc.
Cardiovascular · 107d
Cleared Jun 15, 1984
ACCESS SCANHEADSS
K840953 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 102d
Cleared Jun 15, 1984
ELEVATOR - VARIOUS
K841011 · EMS
Premier Dental Products Co.
Dental · 98d
Cleared Jun 15, 1984
BABYSET TM & PAC TM -PULMONARY ASSIST
K841264 · CAI
Life Design Systems, Inc.
Anesthesiology · 81d
Cleared Jun 15, 1984
NEURO PULSE
K841400 · GZJ
Parker Laboratories, Inc.
Neurology · 73d
Cleared Jun 15, 1984
SCOPE LIGHT
K841825 · HIH
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 44d
Cleared Jun 15, 1984
PULMONARY FUNCTION SYSTEM
K842041 · BZG
Sensor Medics Corp.
Anesthesiology · 25d
Cleared Jun 15, 1984
CONCENTRACTORS
K842114 · CAW
Amox Corp.
Anesthesiology · 73d
Cleared Jun 14, 1984
UREA NITROGEN REAGENT SET
K840064 · CDQ
Sterling Biochemical, Inc.
Chemistry · 157d
Cleared Jun 14, 1984
ALLO-TYPE HUMAN IMMUNOGLOBULIN-
K841114 · DGX
Genetic Testing Institute
Immunology · 91d
Cleared Jun 14, 1984
MONTGOMERY TRACHEAL T-TUBE
K841266 · BTO
E. Benson Hood Laboratories, Inc.
Anesthesiology · 80d
Cleared Jun 14, 1984
DIGITAL SPHYGMOMANOMETER UA-254
K841380 · DXN
Promedical Industries, Inc.
Cardiovascular · 73d
Cleared Jun 14, 1984
DIGITAL SPHYGMOMANOMETER UA-273
K841381 · DXN
Promedical Industries, Inc.
Cardiovascular · 73d
Cleared Jun 14, 1984
RIANEN CYCLIC-AMP RADIOIMMUNOASSAY
K841478 · CHO
New England Nuclear
Chemistry · 66d