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
135649–135672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1988
JAMES TENDOS (SYRINGE HOLDER)
K875297 · FMF
Med-Text Intl.
General Hospital · 111d
Cleared Apr 19, 1988
SAFECATH
K880260 · FOZ
Phase Medical Systems, Inc.
General Hospital · 88d
Cleared Apr 19, 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
K880290 · GQH
Syva Co.
Microbiology · 85d
Cleared Apr 19, 1988
HALF HOUR INFUSOR
K880625 · FRN
Baxter Healthcare Corp
General Hospital · 63d
Cleared Apr 19, 1988
BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200
K880863 · GEI
New England Surgical Instrument Corp.
General & Plastic Surgery · 49d
Cleared Apr 19, 1988
AMYLASE 405 CATALOG NUMBER 301-34
K880867 · JFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 49d
Cleared Apr 19, 1988
MODEL 2001 PHACOEMULSIFIER ASPIRATOR
K880968 · HQE
Mcghan Instrumed Corp.
Ophthalmic · 42d
Cleared Apr 19, 1988
EMIT VANCOMYCIN ASSAY
K881040 · LEH
Syva Co.
Toxicology · 39d
Cleared Apr 19, 1988
OPHTHALMIC SPECTACLE LENS BLANKS
K881225 · HQG
Beta Optical Co, Inc.
Ophthalmic · 28d
Cleared Apr 19, 1988
DECALCIFYING SOLUTION II
K881359 · KOX
Stephens Scientific
General & Plastic Surgery · 19d
Cleared Apr 19, 1988
SUN SHELL (SUN TANNING BED)
K881409 · LEJ
Indoor Sun Systems, Inc.
General & Plastic Surgery · 15d
Cleared Apr 19, 1988
SPIRIX(TM)
K881427 · GEI
Medical/Surgical Specialties, Ltd.
General & Plastic Surgery · 14d
Cleared Apr 19, 1988
MTI WOLFF SYSTEM, TANNING BED
K881492 · LEJ
Health Systems Intl., Inc.
General & Plastic Surgery · 11d
Cleared Apr 18, 1988
SIM 4000C
K874548 · IYO
Ote-Biomedica Elettronica S.P.A
Radiology · 167d
Cleared Apr 18, 1988
THE ESI-2000 ULTRASOUND UNIT
K874683 · IYO
Elscint, Inc.
Radiology · 152d
Cleared Apr 18, 1988
ALBUMIN CAT. # 201-03
K875207 · CIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
CHLORIDE CAT. # 152-17
K875208 · CHJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
GLUCOSE (TRINDER) CAT. # 220-32
K875211 · CGA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
JETPOLISHER AIRPOLISHING POWDER
K875339 · EJR
Young Dental Manufacturing Co. 1, LLC
Dental · 110d
Cleared Apr 18, 1988
ABBOTT IMX T3
K880087 · CDP
Abbott Laboratories
Chemistry · 97d
Cleared Apr 18, 1988
KENSEY CATHETER
K880194 · LIT
Theratek, Inc.
Cardiovascular · 90d
Cleared Apr 18, 1988
URIC ACID REAGENT SET
K880277 · KNK
Tech-Neal Scientific, Inc.
Chemistry · 88d
Cleared Apr 18, 1988
ILLUMINA 40 CO2 LASER SYSTEM
K880427 · EWG
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 77d
Cleared Apr 18, 1988
ILLUMINA 25 CO2 LASER SYSTEM
K880428 · EWG
Cooper Lasersonics, Inc.
Ear, Nose, Throat · 77d