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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,808 results
10489–10512 of 17,808
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 10, 1995
STATLOCK-IPIDURAL
K943038 · FPA
Venetec, Inc.
General Hospital · 287d
Cleared Apr 10, 1995
STERILE PHYSIOLOGICAL SALINE/STERILE WATER
K943661 · JOL
Medcare Custom Packaging, Inc.
General Hospital · 256d
Cleared Apr 10, 1995
LOW VOLUME MULTIPORT
K943770 · FPA
B. Braun of America, Inc.
General Hospital · 251d
Cleared Apr 10, 1995
THE FLEX-SET SUBCUTANEOUS INFUSION SET
K944302 · FOZ
Cathco, Inc.
General Hospital · 216d
Cleared Apr 10, 1995
THE HEART PROTECTOR
K944481 · NXB
Garan Scientific, Inc.
General Hospital · 209d
Cleared Apr 10, 1995
CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC,...
K944763 · LYU
Wells Lamont Corp.
General Hospital · 195d
Cleared Apr 10, 1995
SECURE SAFETY INSERT
K945825 · FMI
Syncor Intl. Corp.
General Hospital · 132d
Cleared Apr 06, 1995
CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY
K945521 · FOZ
Menlo Care, Inc.
General Hospital · 147d
Cleared Apr 05, 1995
CATCO UMBILICAL VESSEL CATHETER
K944336 · FOZ
Catco Medical, Inc.
General Hospital · 211d
Cleared Apr 05, 1995
CATCO POLYURETHANE UMBILICAL VESSEL CATHETER
K944367 · FOZ
Catco Medical, Inc.
General Hospital · 210d
Cleared Apr 05, 1995
CATCO SILICONE UMBILICAL VESSEL CATHETER
K944368 · FOZ
Catco Medical, Inc.
General Hospital · 210d
Cleared Apr 05, 1995
CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER
K944410 · FOZ
Catco Medical, Inc.
General Hospital · 209d
Cleared Apr 04, 1995
POLYDERM
K950033 · LZA
Wilshire Technologies
General Hospital · 90d
Cleared Mar 31, 1995
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · FRC
3M Health Care, Ltd.
General Hospital · 829d
Cleared Mar 31, 1995
CATCO FIRST PICC
K944504 · FOZ
Catco Medical, Inc.
General Hospital · 198d
Cleared Mar 31, 1995
CATO FIRST PICC-DUAL LUMEN
K944685 · LJS
Catco Medical, Inc.
General Hospital · 190d
Cleared Mar 31, 1995
TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES
K944873 · LYZ
Baxter Healthcare Corp
General Hospital · 179d
Cleared Mar 31, 1995
CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE
K950254 · LYY
Cypress Medical Products, Ltd.
General Hospital · 67d
Cleared Mar 29, 1995
SUREWING
K944824 · FPA
Gainor Medical U.S.A., Inc.
General Hospital · 181d
Cleared Mar 29, 1995
LANDMARK MIDLINE CATHETER
K944968 · FOZ
Menlo Care, Inc.
General Hospital · 169d
Cleared Mar 29, 1995
LANDMARK MIDLINE CATHETER
K950737 · FOZ
Menlo Care, Inc.
General Hospital · 41d
Cleared Mar 28, 1995
CLINICAL GLASS THERMOMETER
K942483 · FLK
Makol Medical Instruments Corp.
General Hospital · 307d
Cleared Mar 28, 1995
STATLOCK SECUREMENT DEVICES
K942931 · FPA
Venetec, Inc.
General Hospital · 279d
Cleared Mar 28, 1995
THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE
K945656 · KKX
Micro-Medical Devices, Inc.
General Hospital · 131d