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
132913–132936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 21, 1988
BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET
K884129 · DQY
Bio Medicus, Inc.
Cardiovascular · 82d
Cleared Dec 21, 1988
USCI DORROS INFUSION/PROBING CATHETER
K884209 · DQY
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 76d
Cleared Dec 21, 1988
ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE
K884262 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Dec 21, 1988
INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER
K884390 · KRJ
Medtronic Blood Systems, Inc.
Cardiovascular · 64d
Cleared Dec 21, 1988
MT/S (SOFTWARE RELEASE 3.1)
K884607 · LNH
Diasonics, Inc.
Radiology · 47d
Cleared Dec 20, 1988
AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2
K880586 · HIB
C.I.S.A. Import Export C/O Larson and...
Obstetrics & Gynecology · 313d
Cleared Dec 20, 1988
AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3
K880587 · HIB
C.I.S.A. Import Export C/O Larson and...
Obstetrics & Gynecology · 313d
Cleared Dec 20, 1988
AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4
K880588 · HIB
C.I.S.A. Import Export C/O Larson and...
Obstetrics & Gynecology · 313d
Cleared Dec 20, 1988
ERYTHROPOIETIN ENZYME IMMUNOASSAY
K882686 · GGT
Amgen, Inc.
Hematology · 173d
Cleared Dec 20, 1988
MODIFICATION OF MONO-PLUS(TM)
K883709 · KTN
Armkel, LLC
Immunology · 112d
Cleared Dec 20, 1988
DC-1 I.V. DOSAGE COMPUTER
K884016 · NDC
Phase Medical, Inc.
General Hospital · 89d
Cleared Dec 20, 1988
ERA 2000 EMERGENCY RESUSCITATOR
K884089 · BTL
Neotronics Medical , Ltd.
Anesthesiology · 83d
Cleared Dec 20, 1988
TURBOX ANTITHROMBIN III
K884144 · JBQ
Unipath , Ltd.
Hematology · 81d
Cleared Dec 20, 1988
TURBOX FIBRINOGEN
K884179 · KQJ
Unipath , Ltd.
Hematology · 81d
Cleared Dec 20, 1988
VOXELSCOPE(TM)
K884268 · JAK
Dynamic Digital Displays, Inc.
Radiology · 70d
Cleared Dec 20, 1988
KOTEX STICK TAMPONS, REGULAR AND SUPER
K884305 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 68d
Cleared Dec 20, 1988
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317 · JAA
Medrad, Inc.
Radiology · 68d
Cleared Dec 20, 1988
UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.
K884359 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 64d
Cleared Dec 20, 1988
MAXITHINS SUPER PADS, DEODORANT
K884446 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 60d
Cleared Dec 20, 1988
ROCKET INTRAUTERINE DEPTH SOUND
K884684 · HHM
A & A Medical, Inc.
Obstetrics & Gynecology · 42d
Cleared Dec 20, 1988
MODIFIED 10CC SYRINGE CONTROL RING SET
K884985 · FMF
Procedure Products, Inc.
General Hospital · 19d
Cleared Dec 20, 1988
QM300 PCR ANTIBODY PACK
K885001 · DCN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Dec 19, 1988
CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.
K883488 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 125d
Cleared Dec 19, 1988
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
K883530 · CEP
Tambrands, Inc.
Chemistry · 123d