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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
92977–93000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE - TAMPON
K971541 · KPI
Hollister, Inc.
Gastroenterology & Urology · 58d
Cleared Jun 25, 1997
EMIT II OPIATES 300/2000 ASSAY
K971596 · DJG
Behring Diagnostics, Inc.
Toxicology · 55d
Cleared Jun 25, 1997
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
K971600 · DKB
Behring Diagnostics, Inc.
Toxicology · 55d
Cleared Jun 25, 1997
I-SCOPE OPHTHALMIC ENDOSCOPE
K971679 · MPA
Ophthalmic Technologies, Inc.
Ophthalmic · 49d
Cleared Jun 25, 1997
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
K971841 · LDJ
Bionike Laboratories, Inc.
Toxicology · 37d
Cleared Jun 24, 1997
SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION
K962811 · DXJ
Spacelabs Medical, Inc.
Cardiovascular · 341d
Cleared Jun 24, 1997
SMF TITANIUM (TI) ALLOY BONE SCREWS
K963546 · DZL
Synthes (Usa)
Dental · 292d
Cleared Jun 24, 1997
OPUS PSA TEST SYSTEM
K964595 · LTJ
Behring Diagnostics, Inc.
Immunology · 218d
Cleared Jun 24, 1997
POWDER - FREE LATEX EXAMINATION GLOVES APPLICATION
K964826 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 204d
Cleared Jun 24, 1997
MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14,...
K964974 · GKZ
Dako Corp.
Hematology · 194d
Cleared Jun 24, 1997
VENTED I.V. SET
K965027 · FPA
Jms Co., Ltd.
General Hospital · 189d
Cleared Jun 24, 1997
THAIRAPY VEST SYSTEM
K965192 · BYI
American Biosystems, Inc.
Anesthesiology · 182d
Cleared Jun 24, 1997
ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
K970015 · LZA
Eci Medical Technologies, Inc.
General Hospital · 173d
Cleared Jun 24, 1997
FILTER
K970102 · CAH
Promedic, Inc.
General Hospital · 162d
Cleared Jun 24, 1997
LOW PROTEIN LATEX EXAMINATION GLOVES
K970222 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 154d
Cleared Jun 24, 1997
MASTER NEB II
K970542 · CAF
Bremed Italia, S.R.L.
Anesthesiology · 132d
Cleared Jun 24, 1997
QUANTA LITE B2GPI IGG
K970551 · MSV
Inova Diagnostics, Inc.
Immunology · 132d
Cleared Jun 24, 1997
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
K970612 · DBF
Sealite Sciences, Inc.
Immunology · 126d
Cleared Jun 24, 1997
CLAVE CONNECTOR
K970855 · FPA
Icu Medical, Inc.
General Hospital · 106d
Cleared Jun 24, 1997
ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
K970882 · MPA
American Medical Devices, Inc.
Ophthalmic · 106d
Cleared Jun 24, 1997
BROWNE STEAM INDICATOR
K970918 · JOJ
Board of Directors, Albert Browne , Ltd.
General Hospital · 104d
Cleared Jun 24, 1997
HYDROCOLLOID WOUND DRESSINGS
K971126 · FRO
Innovative Technologies , Ltd.
General & Plastic Surgery · 89d
Cleared Jun 24, 1997
OXYPURE PORTABLE OXYGEN GENERATOR
K971129 · CAW
Arbor Research Corp.
Anesthesiology · 89d
Cleared Jun 24, 1997
SURGICAL DRAPES
K971159 · KKX
International Medsurg Connection
General Hospital · 85d