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
134065–134088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 1988
RK2000 K-THERMIA SYSTEM
K882442 · DWJ
Baxter Healthcare Corp
Cardiovascular · 84d
Cleared Sep 06, 1988
UNDISTAT WITH EXPLORATOR 35 (UCS 35E)
K883153 · IXR
Bay X-Ray, Inc.
Radiology · 42d
Cleared Sep 06, 1988
SELDIX 325 TWO PULSE GENERATOR/CONTROL
K883154 · IZO
Bay X-Ray, Inc.
Radiology · 42d
Cleared Sep 06, 1988
RASTIX X-RAY TABLE
K883155 · KXJ
Bay X-Ray, Inc.
Radiology · 42d
Cleared Sep 06, 1988
TELESTATIX X-RAY TABLE
K883162 · IXR
Bay X-Ray, Inc.
Radiology · 42d
Cleared Sep 06, 1988
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
K883203 · DTB
Medtronic Vascular
Cardiovascular · 40d
Cleared Sep 06, 1988
SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB
K883424 · KKX
Intera Corp.
General Hospital · 22d
Cleared Sep 06, 1988
HERAEUS WHITE
K883512 · EJS
Degussa Dental, Inc.
Dental · 20d
Cleared Sep 06, 1988
BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD
K883602 · DTB
Intermedics, Inc.
Cardiovascular · 14d
Cleared Sep 02, 1988
PHADEBACT ETEC-LT TEST
K874288 · GNA
Pharmacia, Inc.
Microbiology · 318d
Cleared Sep 02, 1988
MULTI-CHEMISTRY LINEARITY STANDARD
K875285 · JIX
Verichem Laboratories, Inc.
Chemistry · 248d
Cleared Sep 02, 1988
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TC
K881674 · JAK
Shimadzu Precision Instruments, Inc.
Radiology · 137d
Cleared Sep 02, 1988
RADKOR XG-325
K881696 · IZO
Radkor, Inc.
Radiology · 136d
Cleared Sep 02, 1988
RADKOR KOB-84
K881700 · KXJ
Radkor, Inc.
Radiology · 136d
Cleared Sep 02, 1988
L-F COILED EXTENSION TUBING
K882329 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 88d
Cleared Sep 02, 1988
HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900
K882365 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 86d
Cleared Sep 02, 1988
LARYNGOSCOPE RIGID
K882433 · CCW
Eastmed Enterprises, Inc.
Anesthesiology · 80d
Cleared Sep 02, 1988
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
K882496 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 77d
Cleared Sep 02, 1988
STACHROM ANTIPLASMIN TEST KIT
K882602 · GGP
American Bioproducts Co.
Hematology · 70d
Cleared Sep 02, 1988
STACHROM ANTIPLASMIN CONTROL
K882603 · GGP
American Bioproducts Co.
Hematology · 70d
Cleared Sep 02, 1988
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K883020 · JJF
Alpkem Corp.
Chemistry · 45d
Cleared Sep 02, 1988
RADKOR, XG-515
K883081 · IZO
Radkor, Inc.
Radiology · 43d
Cleared Sep 02, 1988
AMBU TWIN PUMP - (MANUAL SUCTION PUMP)
K883433 · GCY
Ambu, Inc.
General & Plastic Surgery · 18d
Cleared Sep 02, 1988
C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS
K883521 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 15d