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
127993–128016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1989
GEL-TAC(R)
K895009 · LDD
Padeco, Inc.
Cardiovascular · 127d
Cleared Dec 13, 1989
BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE
K895199 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 117d
Cleared Dec 13, 1989
MODEL ELI-100/ST ELECTROCARDIOGRAPH
K895232 · LOS
Mortara Instrument, Inc.
Cardiovascular · 114d
Cleared Dec 13, 1989
LYME IGG ELISA TEST SYSTEM
K895292 · LSR
Zeus Scientific, Inc.
Microbiology · 110d
Cleared Dec 13, 1989
THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION
K895444 · INW
Mcvicar Enterprises, Ltd.
Physical Medicine · 99d
Cleared Dec 13, 1989
MODEL: IR205 ARTICULATED SURGICAL LASER
K895581 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 89d
Cleared Dec 13, 1989
VASCULAR CLAMP
K895691 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 83d
Cleared Dec 13, 1989
PE INTERCARDIAC MAPPING SYSTEM (ICMS)
K895916 · DRF
Prucka Engineering, Inc.
Cardiovascular · 64d
Cleared Dec 13, 1989
TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS
K896112 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 51d
Cleared Dec 13, 1989
TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS
K896113 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 51d
Cleared Dec 13, 1989
TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.
K896114 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 51d
Cleared Dec 13, 1989
TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER
K896115 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 51d
Cleared Dec 13, 1989
RED DOT CARDIAC SENSOR SYSTEM
K896155 · DRX
3M Company
Cardiovascular · 50d
Cleared Dec 13, 1989
CARDS O.S.(TM) STREP A
K896221 · GTZ
Pacific Biotech, Inc.
Microbiology · 44d
Cleared Dec 13, 1989
MINIMON 7133B PATIENT MONITOR
K896386 · DPS
Kontron Instruments, Inc.
Cardiovascular · 37d
Cleared Dec 13, 1989
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
K896490 · EFQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 30d
Cleared Dec 13, 1989
SPENCO BREAST FORMS
K896533 · KCZ
Spenco Medical Corp.
General & Plastic Surgery · 29d
Cleared Dec 13, 1989
MEDTRONIC MODEL 5401B TEST CABLE
K896632 · DTC
Medtronic Vascular
Cardiovascular · 21d
Cleared Dec 12, 1989
CLOSED CHEST SUPPORT CIRCUIT
K893207 · DTZ
Medtronic Blood Systems, Inc.
Cardiovascular · 230d
Cleared Dec 12, 1989
DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT.
K894355 · LDD
Phycon
Cardiovascular · 151d
Cleared Dec 12, 1989
ZYMED MODEL 1610
K895208 · DSI
Agilent Technologies
Cardiovascular · 117d
Cleared Dec 12, 1989
CALCIUM AND PH ELECTROLYTE ANALYZER
K895397 · JFP
Ionetics, Inc.
Chemistry · 102d
Cleared Dec 12, 1989
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
K895632 · DTZ
3M Company
Cardiovascular · 84d
Cleared Dec 12, 1989
MARQUETTE 1200 DEFIBRILLATION PADS
K895651 · LDD
Marquette Electronics, Inc.
Cardiovascular · 83d