FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
3745–3768 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 18, 1995
RIB RESECTOR
K951492 · HAO
United States Surgical, A Division of...
Neurology · 48d
Cleared May 12, 1995
HEMA-GLU
K951220 · KLE
Health-Dent Intl., Inc.
Dental · 53d
Cleared May 12, 1995
ALL-IN-ONE TWO CHAMBER CONTAINER
K945193 · KPE
Baxter Healthcare Corp
General Hospital · 200d
Cleared May 10, 1995
JPI AUTOMATIC X-RAY FILM PROCESSOR
K950043 · IXW
Jpi Healthcare Co, Ltd.
Radiology · 125d
Cleared May 10, 1995
MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND
K942072 · DXN
Mabis Healthcare, Inc.
Cardiovascular · 376d
Cleared May 10, 1995
MASTERSTIM 1-4
K932075 · IPF
Health Care Assoc.
Physical Medicine · 741d
Cleared May 09, 1995
IMPLANTABLE STAPLE
K950562 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared May 03, 1995
MANUAL SURGICAL INSRUMENT
K951589 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 27d
Cleared May 03, 1995
BAXTER BIOSTAT 1000 UREA MONITOR
K925581 · KXM
Baxter Healthcare Corp
Gastroenterology & Urology · 909d
Cleared Apr 27, 1995
VILA
K951381 · DYH
Health-Dent Intl., Inc.
Dental · 31d
Cleared Apr 27, 1995
VILA PC
K951380 · DYH
Health-Dent Intl., Inc.
Dental · 31d
Cleared Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950522 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 80d
Cleared Apr 27, 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 83d
Cleared Apr 21, 1995
MODEL# 7500 SURVEYOR
K944611 · MNR
Devilbiss Health Care, Inc.
Anesthesiology · 214d
Cleared Apr 20, 1995
GIROC
K951235 · DYH
Health-Dent Intl., Inc.
Dental · 31d
Cleared Apr 18, 1995
PRO-LOCK
K951236 · DYH
Health-Dent Intl., Inc.
Dental · 29d
Cleared Apr 13, 1995
IMPLANTABLE CLIP
K950540 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 65d
Cleared Apr 13, 1995
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
K950164 · CHH
Abaxis, Inc.
Chemistry · 86d
Cleared Apr 10, 1995
ALGI-BAND
K951237 · ELW
Health-Dent Intl., Inc.
Dental · 21d
Cleared Apr 03, 1995
CURASORB ZN ALGINATE WOUND DRESSING
K950775 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 41d
Cleared Mar 31, 1995
TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES
K944873 · LYZ
Baxter Healthcare Corp
General Hospital · 179d
Cleared Mar 31, 1995
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
K944844 · DYF
Baxter Healthcare Corp
Cardiovascular · 182d
Cleared Mar 31, 1995
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · FRC
3M Health Care, Ltd.
General Hospital · 829d
Cleared Mar 24, 1995
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
K951173 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 9d