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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
9313–9336 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 27, 1997
NON-STERILE ISOLATION GOWN
K970814 · FYC
American Seal Co.
General Hospital · 82d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018
K971212 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P
K971213 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825
K971234 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108
K971237 · MRZ
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 23, 1997
VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
K971415 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 36d
Cleared May 23, 1997
VINYL PATIENT EXAMINATION GLOVE, POWDERED
K971423 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 36d
Cleared May 22, 1997
PROSPORE II
K971430 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 35d
Cleared May 20, 1997
PROSPORE
K971432 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 33d
Cleared May 16, 1997
BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)
K964605 · FLL
Thermoscan, Inc.
General Hospital · 179d
Cleared May 16, 1997
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
K970362 · FNM
Apex Metal, Inc.
General Hospital · 105d
Cleared May 14, 1997
REST X SYSTEM
K970428 · FNM
Restxsys
General Hospital · 99d
Cleared May 08, 1997
STERITEC INTEGRAPH MODEL CI-101
K960441 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 462d
Cleared May 07, 1997
VAIL 2000 ENCLOSED BED
K963622 · FNL
Vail Products, Inc.
General Hospital · 239d
Cleared May 07, 1997
INFANT RADIANT WARMER - MODELS IW910 AND IW920
K970432 · FMT
Fisher & Paykel Electronics , Ltd.
General Hospital · 92d
Cleared May 06, 1997
AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM
K955622 · LHI
Baxter Healthcare Corp
General Hospital · 512d
Cleared May 06, 1997
STERITITE SEALED...
K960738 · KCT
Engineered Custom Mfg., Inc.
General Hospital · 438d
Cleared May 06, 1997
DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
K964114 · FXX
Depuy, Inc.
General Hospital · 203d
Cleared May 06, 1997
CYGNUS INSTRUMENT PROTECTORS
K964256 · FRG
Madison Polymeric Engineering
General Hospital · 193d
Cleared May 06, 1997
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared May 06, 1997
SAFESKIN POWDERED EXAMINATION GLOVE
K970899 · LYY
Safeskin Corp.
General Hospital · 56d
Cleared May 06, 1997
SAFE-CONNECT I.V. SET
K970909 · FPA
Faulding Medical Device Co.
General Hospital · 55d
Cleared May 02, 1997
BASIS FLEXIBLE TIP DIGITAL THERMOMETER
K971045 · FLL
Polymedica Industries, Inc.
General Hospital · 42d
Cleared May 01, 1997
SAFE-CONNECT VIAL DISPENSING SPIKE
K970789 · LHI
Faulding Medical Device Co.
General Hospital · 58d